Medline
ResiStat/Xalt Backtable Cover with Xalt Barrier Fabric Reinforcement, Green, 60" x 90"
39manufacturers in China registered for this device type
517catalogue numbers in this listing
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (14), Zhejiang (6), Guangdong (6). 21 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Jiangsu Likang Medical Products Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 17 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Wuhan Huaxin Nonwoven Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 13 |
| Foshan Nanhai Plus Medical Co Ltd | Foshan | Guangdong | Contract manufacturer | 12 |
| Kunshan Jiehong Nonwoven Product Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 12 |
Showing 12 of 39. All 39 manufacturers in China registered for Drape, Surgical, Antimicrobial
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | KKX |
| Device type | Drape, Surgical, Antimicrobial |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| 510(k) | K962205 |
| Record published | 2020-11-12 |
| Record revised | 2026-01-15 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: avoid contact with an open flame or high intensity heat source |
| Packaging | Pack of 12, pack of 20, pack of 100, pack of 50, pack of 10, pack of 40 |
| Sizes | Length 28 to 145 in; width 49.75 to 128 in |
| Distribution end date | 2026-03-11 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MDTZ1027049CG | 72 | In distribution | |
| MDTZ1012735BC | 72 | In distribution | |
| 174985 | In distribution | ||
| MDTZ1008039AB | 24 | In distribution | |
| SPT-5610SCS | In distribution | ||
| DYNJP2410 | In distribution | ||
| 66793 | In distribution | ||
| DYNJP10030 | In distribution | ||
| MED561 | In distribution | ||
| DYNJSD1017 | In distribution | ||
| DYNJP8201UG | In distribution | ||
| DYNJP9108 | In distribution | ||
| SPT-2505CS | In distribution | ||
| DYNJSF01GS | In distribution | ||
| 66525 | In distribution | ||
| SCD301 | In distribution | ||
| SPT-3590SCS | In distribution | ||
| MDTZ1008778AA | 48 | In distribution | |
| MDT013637 | In distribution | ||
| 299479002 | In distribution | ||
| MDTZ1025127AA | In distribution | ||
| MDTZ1011767BB | In distribution | ||
| 81684CS | In distribution | ||
| 55211 | In distribution | ||
| D-14703-001 | In distribution | ||
| DYNJP4118A | In distribution | ||
| 14185CS | In distribution | ||
| MDTZ1190140AH | In distribution | ||
| D-45703003A | In distribution | ||
| SPT-2457SCS | In distribution | ||
| SPT-2451SCS | In distribution | ||
| 243-24X30CS | 600 | In distribution | |
| SPT-4142CS | In distribution | ||
| M-05503-001 | In distribution | ||
| SRI3040 | In distribution | ||
| MDTZ1022481AE | In distribution | ||
| 29522CS | In distribution | ||
| MDTR1015747BB | In distribution | ||
| MDTZ1023438AB | In distribution | ||
| SPT-2520SCS | In distribution | ||
| DYNJP4107 | In distribution | ||
| SPT-4102CS | In distribution | ||
| MDTZ1087930AM | In distribution | ||
| CCT1192 | 15 | In distribution | |
| MDTAUS13636 | 12 | In distribution | |
| 48995CS | In distribution | ||
| K-05501-003 | In distribution | ||
| 66578 | In distribution | ||
| MDTZ1010321AA | 12 | In distribution | |
| MDT013677 | In distribution | ||
| MDTZ1061244AD | In distribution | ||
| SPT-0137CS | In distribution | ||
| 66920 | In distribution | ||
| 30024CS | In distribution | ||
| DYNJP2220 | 2 | In distribution | |
| SPT-2009SMSCS | 100 | In distribution | |
| SPT-5090SCS | In distribution | ||
| DYNJP4131 | Width 83 in | In distribution | |
| MED599NS | In distribution | ||
| MDTZ1027049CF | 72 | In distribution | |
| 55875 | In distribution | ||
| MDTZ1060198AU | In distribution | ||
| MDTZ1016319AB | In distribution | ||
| MDTZ1087930AD | In distribution | ||
| DYNJSD6640 | In distribution | ||
| SPT-4201SCS | In distribution | ||
| MDTZ1015434BC | In distribution | ||
| MDT2168204B | 4 | In distribution | |
| DYNJP8412UG | In distribution | ||
| MDTZ1012235AS | In distribution | ||
| 66952 | In distribution | ||
| 66731 | In distribution | ||
| SPT-8290ACS | In distribution | ||
| 31482CS | 100 | In distribution | |
| DYNJP2416 | In distribution | ||
| MDTAUS13632 | 12 | In distribution | |
| 40055 | In distribution | ||
| H-02220-001A | In distribution | ||
| 27478CS | In distribution | ||
| 66044 | In distribution | ||
| DYNJP3005UG | In distribution | ||
| 12147ACS | In distribution | ||
| MDTZ1001866AA | 12 | In distribution | |
| 60864 | In distribution | ||
| MDTZ1006881AA | 24 | In distribution | |
| SYN3875 | In distribution | ||
| DYNJP10040 | In distribution | ||
| MDTZ1008778AA | In distribution | ||
| DYNJP4006 | In distribution | ||
| DYNJP8002 | Length 89 in | In distribution | |
| 60845 | In distribution | ||
| MDTZ1015098LD | In distribution | ||
| MDTZ1015887BA | 12 | In distribution | |
| 66703 | In distribution | ||
| MDTZ1022190AE | In distribution | ||
| MDTL1410275Q | 12 | In distribution | |
| DYNJP4102 | In distribution | ||
| DYNJSDX2021 | In distribution | ||
| SPT-4106SCS | In distribution | ||
| MDTL1410275F | 12 | In distribution | |
| D-05060-001 | In distribution | ||
| DYNJCD0036 | In distribution | ||
| DYNJP2411 | In distribution | ||
| DYNJP4114 | In distribution | ||
| 66619 | In distribution | ||
| 299427002 | In distribution | ||
| 14184CS | In distribution | ||
| MDT013678 | In distribution | ||
| K-09806-001A | In distribution | ||
| SPT-DRAPXLSCS | In distribution | ||
| 170978NS | 20 | In distribution | |
| MDTZ1003635AC | In distribution | ||
| DYNJP6003 | In distribution | ||
| DYNJP3011 | Length 122 in | In distribution | |
| DYNJP4122 | In distribution | ||
| D-04306-001 | In distribution | ||
| 299398002 | In distribution | ||
| SPT-DRAPLGSCS | In distribution | ||
| DYNJP5001 | In distribution | ||
| 67584 | In distribution | ||
| MDTZ1017549CB | In distribution | ||
| ECL4142 | In distribution | ||
| ECL0038 | In distribution | ||
| MDTZ1011767BB | 12 | In distribution | |
| MDTZ1256480AA | In distribution | ||
| DYNJP7012 | In distribution | ||
| 66066 | In distribution | ||
| MDTMAYOS | In distribution | ||
| 60815 | In distribution | ||
| DYNJCD0007 | In distribution | ||
| SPT-2540SCS | In distribution | ||
| 29677ACS | In distribution | ||
| 66261 | In distribution | ||
| 07164CS | In distribution | ||
| ECO2410 | In distribution | ||
| 66251 | In distribution | ||
| MDTL1410275F | In distribution | ||
| MDTZ1099543AA | In distribution | ||
| 1120S | In distribution | ||
| ME447 | In distribution | ||
| 55731 | 2 | In distribution | |
| MDTZ1173034HD | In distribution | ||
| DYNJSD6650 | In distribution | ||
| 75-2165 | In distribution | ||
| 66886 | In distribution | ||
| 88192CS | In distribution | ||
| 66782 | In distribution | ||
| DYNJP4014 | In distribution | ||
| 68576 | In distribution | ||
| MC010NSKA | In distribution | ||
| H-05159-001 | In distribution | ||
| NON21002 | In distribution | ||
| DYNJP8104 | In distribution | ||
| DNSCTM14937 | In distribution | ||
| 170517B | In distribution | ||
| DYNJP2414R | In distribution | ||
| 05166CS | In distribution | ||
| 66737 | In distribution | ||
| MDTZ1045066AB | In distribution | ||
| MDTZ1011139AB | 12 | In distribution | |
| MDTZ1016319AB | 12 | In distribution | |
| D-14703-002A | In distribution | ||
| MDTZ1008037CA | 12 | In distribution | |
| ECO3003 | In distribution | ||
| 05136CS | In distribution | ||
| 60795 | In distribution | ||
| 08454CS | In distribution | ||
| SPT-5590SCS | In distribution | ||
| MDTZ1015791AB | In distribution | ||
| MDT013672 | In distribution | ||
| SYN2034 | In distribution | ||
| KMS-04 | 25 | In distribution | |
| 66222 | In distribution | ||
| DYNJP2494 | 4 | In distribution | |
| MDT013632 | In distribution | ||
| SPT-2450SCS | In distribution | ||
| 66739 | In distribution | ||
| 60819 | In distribution | ||
| MDTL1006151BS | In distribution | ||
| DYNJP3007UG | In distribution | ||
| 195579001 | In distribution | ||
| DYNJP2414C | 2 | In distribution | |
| MDT013631 | In distribution | ||
| MDTZ1022481BA | In distribution | ||
| 66879 | In distribution | ||
| MDTZ1022382DD | In distribution | ||
| MDTZ1012235AS | 12 | In distribution | |
| SPT-3712SCS | In distribution | ||
| MDTZ1012735BA | 72 | In distribution | |
| 40006 | In distribution | ||
| MDTZ1233430AA | In distribution | ||
| MDTZ1060198AH | In distribution | ||
| DYNJP2216 | 2 | In distribution | |
| MDTZ1045066AA | In distribution | ||
| MDTZ1208931AA | In distribution | ||
| K09807-001A | In distribution | ||
| 47234CS | In distribution | ||
| MDT013633 | In distribution | ||
| 50613 | 2 | In distribution | |
| DYNJSD4500S | In distribution | ||
| DYNJP8016 | In distribution | ||
| MDT013634 | In distribution | ||
| MDTZ1011139AD | In distribution | ||
| MDT013695 | In distribution | ||
| CMP297 | 25 | In distribution | |
| SRI3015 | In distribution | ||
| DYNJSD6617 | In distribution | ||
| DYNJSD1020 | In distribution | ||
| 60915 | In distribution | ||
| SRI3351 | In distribution | ||
| 60965 | In distribution | ||
| SPT-3570SCS | In distribution | ||
| DC103 | In distribution | ||
| DYNJP2220 | 2 | In distribution | |
| 75-1040 | In distribution | ||
| MDTR1015747BB | 12 | In distribution | |
| MDTL1006151BS | 12 | In distribution | |
| MDT013683 | In distribution | ||
| MDTZ1007972BE | 24 | In distribution | |
| MDTZ1017192AA | In distribution | ||
| MDTL1002671BS | 12 | In distribution | |
| MDTZ1015887BA | In distribution | ||
| SPT-2320CS | In distribution | ||
| 55950 | In distribution | ||
| MDTZ1004998SQ | In distribution | ||
| DYNJSD2114 | In distribution | ||
| SPT-2640SCS | In distribution | ||
| DYNJSD6697 | In distribution | ||
| MDT013622 | In distribution | ||
| SPT-3575SCS | In distribution | ||
| DYNJP2420 | In distribution | ||
| MDT013380 | Length 37 in | In distribution | |
| DYNJSD1061 | In distribution | ||
| DYNJP8013 | In distribution | ||
| SPT-3820SCS | In distribution | ||
| MDTZ1010324AD | 12 | In distribution | |
| SPT-8406SCS | In distribution | ||
| L05000-005A | In distribution | ||
| MDTZ1022190AC | In distribution | ||
| MDT013673H | In distribution | ||
| MDTZ1021920AA | In distribution | ||
| DYNJP9003 | Width 64 in | In distribution | |
| C-05500-001C | In distribution | ||
| SPT-2490CS | In distribution | ||
| SPT-2456SCS | In distribution | ||
| MDTAUS13632 | In distribution | ||
| 66950 | In distribution | ||
| DYNJSD1023 | In distribution | ||
| MDT2168294 | 4 | In distribution | |
| 31358CS | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microtek | Microtek Medical LLC | 994 |
| Exact Medical Manufacturing, Inc. | Exact Medical Manufacturing, Inc. | 819 |
| Halyard | O&M Halyard, Inc. | 800 |
| Convertors | Cardinal Health 200, LLC | 392 |
| Medline Industries, Inc. | Medline Industries, Inc. | 274 |
| TIDIShield | Tidi Products, LLC | 187 |
| DeRoyal | Deroyal Industries, Inc. | 118 |
| Cardinal Health | Cardinal Health 200, LLC | 111 |
| Angiosystems Drape | Angiosystems, Inc. | 109 |
| ComPel Surgical Drape | Standard Textile Co., Inc. | 101 |
| Drape, Surgical, Antimicrobial | Welmed, Inc. | 95 |
| Novo Health Services, LLC | Novo Health Services, LLC | 90 |
Showing 12 of 329. All products under Drape, Surgical, Antimicrobial
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K052833 | 2006-02-15 |
| K032666 | 2005-03-16 |
| K023432 | 2002-11-04 |
| K964142 | 1997-02-25 |
| K962205 | 1996-11-26 |
| K791070 | 1979-06-20 |
Recalls Naming This Product
7 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Under Investigation by firm | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 14,927,765 units | |
| Medline Industries, LP – Northfield | 510(k) number | 2026-01-07 | Class II | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 240 units | |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 14927765 units | |
| Medline Industries, LP – Northfield | UDI-DI | 2025-02-13 | Class II | Packaging process control | Potential breach in pouch packaging which could lead to loss of sterility. | 1,482 units | |
| Medline Industries, LP – Northfield | 510(k) number | 2024-04-08 | Class II | Under Investigation by firm | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | ||
| Medline Industries, LP – Northfield | 510(k) number | 2022-12-07 | Class II | Under Investigation by firm | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile. | 0 units | |
| Medline Industries, LP – Northfield | 510(k) number | 2003-10-07 | Not classified | Other | The product, labeled as sterile, had not gone through the sterilization process at the time of shipment. | 44 cases | 2003-11-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.