Medline Industries, Inc.
DBD-Gown,cool-Zone,fabric-Reinforced,lg
39manufacturers in China registered for this device type
274catalogue 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) | K850960 |
| Record published | 2016-11-07 |
| Record revised | 2026-02-02 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 20, case of 10, case of 100, pack of 10, case of 30, pack of 20 |
| Sizes | Length 50 in; width 35 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14184ACS | In distribution | |
| DYNJ902031 | In distribution | |
| DYNJ38963B | In distribution | |
| DYNJCD0133 | In distribution | |
| 08454CS | In distribution | |
| DYNJPX3082 | In distribution | |
| DYNJZ12141 | In distribution | |
| DYNJCD0012 | In distribution | |
| DYNJ0406118K | In distribution | |
| SPT-4207SCS | In distribution | |
| DYNJCD0269 | In distribution | |
| DYNJCD0072 | In distribution | |
| DYNJ24352 | In distribution | |
| 31358CS | In distribution | |
| DYNJCD0214 | In distribution | |
| DYNJ0545058O | In distribution | |
| SPT-2432SCS | In distribution | |
| DYNJ903720 | In distribution | |
| DYNJ38878 | In distribution | |
| PHS516876002 | In distribution | |
| 35667CS | In distribution | |
| SPT-3580SCS | In distribution | |
| DYNJ51747 | In distribution | |
| DYNJ49041F | In distribution | |
| DYKA1060 | In distribution | |
| DYNJCD0083 | In distribution | |
| DYNJ44970B | In distribution | |
| DYNJCD0219 | In distribution | |
| DYNJ31452D | In distribution | |
| DYNJ42565 | In distribution | |
| DYNJ0396207F | In distribution | |
| P207846A | In distribution | |
| DYNJ51740 | In distribution | |
| DYKM1306 | In distribution | |
| DYNJ38095 | In distribution | |
| DYNJ37265F | In distribution | |
| DYNJCD0063 | In distribution | |
| SPT-3815SCS | In distribution | |
| DYK1006300I | In distribution | |
| DYNDM1062 | In distribution | |
| DYNJ32899A | In distribution | |
| P123060 | In distribution | |
| DYNJCD0088 | In distribution | |
| SPT-2555SCS | In distribution | |
| DYNJCD0091A | In distribution | |
| DYNJCD0239 | In distribution | |
| DYKM1324 | In distribution | |
| 05580CS | In distribution | |
| SPT-10010SCS | In distribution | |
| SAMP0439 | In distribution | |
| DYNJCD0092 | In distribution | |
| DYNJ50738 | In distribution | |
| DYNJ36694B | In distribution | |
| DNSC16908 | In distribution | |
| DNSC86697 | In distribution | |
| DNSC120928 | In distribution | |
| DYNJ50005 | In distribution | |
| PAINDRAPE4 | In distribution | |
| DYNJCD0119A | In distribution | |
| DYNJCD0130 | In distribution | |
| 61024CS | In distribution | |
| 00-399027L | In distribution | |
| DYKM1308 | In distribution | |
| SPT-2451SCS | In distribution | |
| DYNJ0373061I | In distribution | |
| DYNJ45682 | In distribution | |
| DYNJCD0170 | In distribution | |
| DYKM1200A | In distribution | |
| P122412 | In distribution | |
| 10-7706A | In distribution | |
| DYNJCD0270 | In distribution | |
| DYNJ36314J | In distribution | |
| DYNJ48392A | In distribution | |
| 10301CS | In distribution | |
| DYNJ0545058N | In distribution | |
| 14184RCS | In distribution | |
| SPT-2560SCS | In distribution | |
| SPT-4162CS | In distribution | |
| SAMP0475 | In distribution | |
| CDS984916D | In distribution | |
| SPT-4216SCS | In distribution | |
| SPTPCD10005 | In distribution | |
| 31359CS | In distribution | |
| DYNJ53245 | In distribution | |
| DYNJ43665 | In distribution | |
| DYNJCS0262 | In distribution | |
| DYNJ41018 | In distribution | |
| DYNJ903723 | In distribution | |
| SPT-3160SCS | In distribution | |
| DYNJ45682A | In distribution | |
| CDS984475B | In distribution | |
| SPT-8404SCS | In distribution | |
| DYKA1208 | In distribution | |
| DNSC18494 | In distribution | |
| DYNJ0209716K | In distribution | |
| DYNJ02197B | In distribution | |
| DYKD1013275I | In distribution | |
| DYNJ32372C | In distribution | |
| DYNJ32372B | In distribution | |
| DYNJCD0078A | In distribution | |
| DYNJCD0242 | In distribution | |
| DYNJ0796077C | In distribution | |
| SPT-2462LCS | In distribution | |
| DYNJ0966737C | In distribution | |
| SPTPCD10017C | In distribution | |
| PAINDRAPE2 | In distribution | |
| 48545CS | In distribution | |
| DYNJ0373061J | In distribution | |
| SPT-8290ACS | In distribution | |
| 31362CS | In distribution | |
| SPTPCD10019 | In distribution | |
| DYKM1328 | In distribution | |
| DYNJ0777519B | In distribution | |
| DYNJ50005A | In distribution | |
| 37467CS | In distribution | |
| DYNJ0818397Y | In distribution | |
| DYNJ53058 | In distribution | |
| 299398001 | In distribution | |
| DYNJ902065 | In distribution | |
| DYNJCD0101A | In distribution | |
| DYNJ42065B | In distribution | |
| DYNJ903538B | In distribution | |
| DYNJ35497A | In distribution | |
| DYNJ47600A | In distribution | |
| DYNJCD0241 | In distribution | |
| DYKM1545 | In distribution | |
| DYNJ50232 | In distribution | |
| DYNJZ90079 | In distribution | |
| DYNJCD0040 | In distribution | |
| DYNJCD0230 | In distribution | |
| DYNJ42067 | In distribution | |
| DYNJ55530 | In distribution | |
| DYNJ0233004D | In distribution | |
| DYNJ22911I | In distribution | |
| SPT-8270SCS | In distribution | |
| DYNJ52699 | In distribution | |
| DYNJCD0016 | In distribution | |
| 61026CS | In distribution | |
| SPT-8610SCS | In distribution | |
| PAINDRAPE3 | In distribution | |
| SPT-4204SCS | In distribution | |
| D-09875-001 | Length 50 in | In distribution |
| DYNJ66800 | In distribution | |
| DYNJ27732 | In distribution | |
| DYNJ0406118J | In distribution | |
| 37078CS | In distribution | |
| DYNJ55522 | In distribution | |
| DYNJ23258A | In distribution | |
| DYNJCD0223 | In distribution | |
| DYNJ43214G | In distribution | |
| DYNJ51631 | In distribution | |
| DYNJCD0248 | In distribution | |
| SPTPCD10002 | In distribution | |
| SPT-5591SCS | In distribution | |
| DYNJ0160540B | In distribution | |
| DYNJZ87176 | In distribution | |
| DYK1009229M | In distribution | |
| 58671 | In distribution | |
| DYNJCD0235 | In distribution | |
| DYNJPX8103 | In distribution | |
| 15648CS | In distribution | |
| SPT-4102CS | In distribution | |
| SPT-4118ACS | In distribution | |
| DYK1012252I | In distribution | |
| DYNJ48373A | In distribution | |
| DYNJCD0280 | In distribution | |
| DYNJ04700B | In distribution | |
| 05528CS | In distribution | |
| SPT-2550SCS | In distribution | |
| DYNJ900648D | In distribution | |
| DYNJCD0127 | In distribution | |
| DYNJCD0232 | In distribution | |
| DYNJPE2104 | In distribution | |
| DYNJCD0010 | In distribution | |
| DYNJCD0119 | In distribution | |
| 26194CS | In distribution | |
| SVI-1020 | In distribution | |
| 110347CS | In distribution | |
| DYNJCD0097B | In distribution | |
| DYNJCD0082B | In distribution | |
| DYNJ39689D | In distribution | |
| DYNJ903545C | In distribution | |
| DYNJCD0079 | In distribution | |
| DYNJ49087 | In distribution | |
| DYNJ49315A | In distribution | |
| SPT-8620SCS | In distribution | |
| SPT-2510SCS | In distribution | |
| DYNJ43815C | In distribution | |
| SPT-2462RCS | In distribution | |
| DYNJ49041A | In distribution | |
| 29677ACS | In distribution | |
| DYNJ41349A | In distribution | |
| DYNJCD0238 | In distribution | |
| DYNJCD0205 | In distribution | |
| PHS256635000 | In distribution | |
| DNSC42334 | In distribution | |
| DYNJ903698 | In distribution | |
| DYNJ0418305G | In distribution | |
| DYNJ0867273B | In distribution | |
| SAMP0441 | In distribution | |
| DYKD1011857I | In distribution | |
| DYK1008521I | In distribution | |
| PHS41727000 | In distribution | |
| DYNJP5002 | In distribution | |
| SYNJ10228 | In distribution | |
| SPT-4208SCS | In distribution | |
| DYNJ0813327G | In distribution | |
| DYNJCD0194B | In distribution | |
| DYNJX12891 | In distribution | |
| DYNJ47058 | In distribution | |
| DYNJCD0272 | In distribution | |
| DYNJCD0095A | In distribution | |
| DYNJ24229 | In distribution | |
| SPT-2495CS | In distribution | |
| DYNJ904390 | In distribution | |
| DYNJX13295 | In distribution | |
| SPT-3711SCS | In distribution | |
| DYNJ82663B | In distribution | |
| PAINDRAPE1 | In distribution | |
| SPTPCD10015 | In distribution | |
| DYNJ55399 | In distribution | |
| ENGMICROLG2 | In distribution | |
| DYNJCD0217 | In distribution | |
| DYK1058418I | In distribution | |
| DYNJ53977 | In distribution | |
| DYNJ0429259C | In distribution | |
| 11348CS | In distribution | |
| DYNJCD0236 | In distribution | |
| DYNJCD0047A | In distribution | |
| DYK1166226I1 | In distribution | |
| DYNJ43543A | In distribution | |
| DYNJ903126 | In distribution | |
| 84283CS | In distribution | |
| DNSC49859 | In distribution | |
| DYNJ0618509F | In distribution | |
| DYNJCD0044 | In distribution | |
| DYNJZXODNS80710 | In distribution | |
| DYNJ37343A | In distribution | |
| DYNJZ07329 | In distribution | |
| DYNJCD0090A | In distribution | |
| SPT-3595SCS | In distribution | |
| DYNJ44114 | In distribution | |
| DYNJ52889 | In distribution | |
| DYNJ37265D | In distribution | |
| SPT-5610SCS | In distribution | |
| SPT-2323CS | In distribution | |
| DYNJ49266A | In distribution | |
| 61025CS | In distribution | |
| DYNJCD0229 | In distribution | |
| DYNJV0170J | In distribution |
Showing 250 of 274 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 |
| Medline | Medline Industries, Inc. | 517 |
| Convertors | Cardinal Health 200, LLC | 392 |
| 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.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-27 | Class II | Component change control | Unapproved design changes to the products outside of the 510(k) clearance. | 270,311 total |
| 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 | 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 | 240 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-03-03 | Class II | Under Investigation by firm | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. | 90 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-09-04 | Class II | Under Investigation by firm | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. | 194 units |
| Medline Industries, LP – Northfield | UDI-DI | 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 | UDI-DI | 2022-11-17 | Class II | Device Design | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | 5 cases (5 units) |
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.