Lac-Mac
Mayo Stand Cover, 53 X 27, Level 4, Customer Supplied Barcode in specified location
39manufacturers in China registered for this device type
45catalogue numbers in this listing
1510(k) clearance
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 | LAC-MAC Limited, Canada |
|---|---|
| FDA product code | KKX |
| Device type | Drape, Surgical, Antimicrobial |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K031362 |
| Record published | 2020-03-23 |
| Record revised | 2021-02-05 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Width 26.5 to 140 in; height 21.5 to 130 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 025XNAB | Width 100 in | In distribution |
| 025XC | Height 60 in | In distribution |
| 025XNAA | Width 54 in | In distribution |
| 025XNAD | Height 70 in | In distribution |
| 025YF | Height 72 in | In distribution |
| 026YRAF | Height 70 in | In distribution |
| 075XA | Width 54 in | In distribution |
| 026YE | Height 72 in | In distribution |
| 075XV | Width 53 in | In distribution |
| 075XVAA | Height 28 in | In distribution |
| 024XGAA | Height 32 in | In distribution |
| 090XA | Height 44 in | In distribution |
| 025ZS | Height 58 in | In distribution |
| 091XSAB | Height 68 in | In distribution |
| 075XAAK | Width 26.5 in | In distribution |
| 026XC | Height 72 in | In distribution |
| 035CNAA | Height 50 in | In distribution |
| 026XE | Height 72 in | In distribution |
| 026XGAK | Height 90 in | In distribution |
| 025XNAE | Width 70 in | In distribution |
| 075XVAB | Height 27 in | In distribution |
| 025ZSAA | Height 58 in | In distribution |
| 084BBTQ | Height 60 in | In distribution |
| 025XD | Width 90 in | In distribution |
| 091XQ | Width 70 in | In distribution |
| 024XU | Width 98 in | In distribution |
| 025XNAC | Width 70 in | In distribution |
| 091YK | Height 80 in | In distribution |
| 075XX | Height 27 in | In distribution |
| 075XAAF | Width 54 in | In distribution |
| 026YS | Width 113 in | In distribution |
| 025ZRAA | Height 60 in | In distribution |
| 025XXAA | Width 65 in | In distribution |
| 026XJ | Height 72 in | In distribution |
| 026YUAE | Width 130 in | In distribution |
| 026YQ | Width 132 in | In distribution |
| 025XX | Height 56 in | In distribution |
| 025XV | Height 51 in | In distribution |
| 091XP | Width 108 in | In distribution |
| 025YC | Height 57 in | In distribution |
| 025XDAF | Height 72 in | In distribution |
| 025ZR | Height 60 in | In distribution |
| 024XL | Height 72 in | In distribution |
| 075XAAL | Width 55 in | In distribution |
| 025YH | Height 83 in | In distribution |
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 |
| 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 |
Showing 12 of 329. All products under Drape, Surgical, Antimicrobial
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K031362 | 2003-05-30 |
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.