Lac-Mac
Surgical Gown, Level 4, special color code, grips on neckband, special barcode inside front yoke, RF chip, custom sizing, patented Size 2XL
68manufacturers in China registered for this device type
157catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (16), Hubei (13), Anhui (10). 28 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 |
| Henan Yadu Industrial Co., Ltd. | Changyuan | Henan | Contract manufacturer | 35 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Kingstar Medical (Xianning) Co., Ltd. | Xianning | Hubei | Contract manufacturer | 17 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Weihai Dishang Medical Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 16 |
| Lianyungang Bronson Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
Showing 12 of 68. All 68 manufacturers in China registered for Gown, Surgical
Record
| Listed by | LAC-MAC Limited, Canada |
|---|---|
| FDA product code | FYA |
| Device type | Gown, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K092344 |
| Record published | 2016-09-21 |
| Record revised | 2021-04-07 (version 7) |
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 | Height 48.5 to 59.5 in; width 19 to 57.25 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 005XFAB-XL | Height 56.25 in | In distribution |
| 005XEAL-2XL | Height 59 in | In distribution |
| 005ABAM-M | Width 25 in | In distribution |
| 005ABAL-S | Width 25 in | In distribution |
| 005XFAP-XS | Width 19 in | In distribution |
| 005XH-L | Height 51.5 in | In distribution |
| 005XFAE-M | Height 54.25 in | In distribution |
| 005XEAC-XL | Height 56.25 in | In distribution |
| 005XFAH-M | Width 57.25 in | In distribution |
| 005XX-2XL | Height 57.25 in | In distribution |
| 005XFAP-2XL | Height 57.25 in | In distribution |
| 005XX-XS | Width 19 in | In distribution |
| 005XEAB-XS | Width 19 in | In distribution |
| 005XFAP-4XL | Height 58.25 in | In distribution |
| 005XF-3XL | Width 21 in | In distribution |
| 005XFAH-5XL | Height 57.25 in | In distribution |
| 005XX-3XL | Height 58.25 in | In distribution |
| 005XEAK-S | Height 53.25 in | In distribution |
| 005XH-M | Height 50.5 in | In distribution |
| 005XFAB-L | Height 55.25 in | In distribution |
| 005XE-XL | Width 27 in | In distribution |
| 005XFAO-L | Height 56.25 in | In distribution |
| 005XEAO-XL | Height 56.25 in | In distribution |
| 005XXAE-XS | Height 52.25 in | In distribution |
| 005XFAE-3XL | Height 58.25 in | In distribution |
| 005XXCE-4XL | Height 59.25 in | In distribution |
| 005XEAE-M | Height 54.25 in | In distribution |
| 005XEAA-L | Width 25 in | In distribution |
| 005XFAB-2XL | Height 57.25 in | In distribution |
| 005XEAA-3XL | Width 31 in | In distribution |
| 005XEAK-XL | Height 56.25 in | In distribution |
| 005XXAE-L | Height 55.25 in | In distribution |
| 005XEAK-2XL | Height 57.25 in | In distribution |
| 005XEAG-M | Height 54.25 in | In distribution |
| 005XEAO-2XL | Height 57.25 in | In distribution |
| 005XPAB-2XL | Height 53.5 in | In distribution |
| 005XFAB-XS | Height 52.25 in | In distribution |
| 005XX-L | Height 55.25 in | In distribution |
| 005XPAB-L | Height 52.5 in | In distribution |
| 005XF-XL | Width 21 in | In distribution |
| 005XXCB-S | Width 25 in | In distribution |
| 005XEAB-XL | Height 56.25 in | In distribution |
| 005XEAA-XL | Width 27 in | In distribution |
| 005XXCB-M | Width 25 in | In distribution |
| 005XE-3XL | Width 31 in | In distribution |
| 005ABAM-XL | Width 25 in | In distribution |
| 005XXCE-3XL | Height 58.25 in | In distribution |
| 005XEAA-XS | Height 51.25 in | In distribution |
| 005XXCA-M | Width 25 in | In distribution |
| 005XFAE-XS | Width 19 in | In distribution |
| 005ABAM-2XL | Width 25 in | In distribution |
| 005XE-S | Width 21 in | In distribution |
| 005XXBN-4XL | Height 59.25 in | In distribution |
| 005XFAE-L | Height 55.25 in | In distribution |
| 005XFAP-S | Height 53.25 in | In distribution |
| 005XXBN-2XL | Height 57.25 in | In distribution |
| 005XXCA-XL | Width 25 in | In distribution |
| 005XEAK-XS | Width 19 in | In distribution |
| 005XPAB-XL | Height 53 in | In distribution |
| 005XP-XL | Height 53 in | In distribution |
| 005XEAE-3XL | Height 58.25 in | In distribution |
| 005XF-2XL | Width 21 in | In distribution |
| 005XXCB-2XL | Width 25 in | In distribution |
| 005XH-3XL | Height 54.5 in | In distribution |
| 005XEAC-XS | Width 19 in | In distribution |
| 005XEAC-3XL | Height 58.25 in | In distribution |
| 005XEAA-2XL | Width 29 in | In distribution |
| 005XFAP-3XL | Height 58.25 in | In distribution |
| 005XEAG-XL | Height 56.25 in | In distribution |
| 005XFAH-2XL | Height 57.25 in | In distribution |
| 005XXCA-S | Width 25 in | In distribution |
| 005XFAP-XL | Height 56.25 in | In distribution |
| 005XEAA-S | Width 21 in | In distribution |
| 005XF-S | Width 21 in | In distribution |
| 005XFAH-L | Height 57.25 in | In distribution |
| 005XXBN-XL | Height 56.25 in | In distribution |
| 005XFAE-S | Height 53.25 in | In distribution |
| 005XE-M | Width 23 in | In distribution |
| 005XX-S | Height 53.25 in | In distribution |
| 005ABAM-L | Width 25 in | In distribution |
| 005XFAJ-4XL | Height 59.25 in | In distribution |
| 005XEAB-M | Height 54.25 in | In distribution |
| 005XEAB-3XL | Height 58.25 in | In distribution |
| 005ABAL-2XL | Width 25 in | In distribution |
| 005XEAC-2XL | Height 57.25 in | In distribution |
| 005ABAL-L | Width 25 in | In distribution |
| 005XXBN-M | Height 54.25 in | In distribution |
| 005XEAB-S | Height 53.25 in | In distribution |
| 005XEAO-M | Height 54.25 in | In distribution |
| 005XFAB-S | Height 53.25 in | In distribution |
| 005XFAB-3XL | Height 58.25 in | In distribution |
| 005XXBN-3XL | Height 58.25 in | In distribution |
| 005XX-M | Height 54.25 in | In distribution |
| 005XH-XL | Height 52.5 in | In distribution |
| 005XFAQ-M | Height 57.25 in | In distribution |
| 005XF-L | Width 21 in | In distribution |
| 005XEAC-S | Height 53.25 in | In distribution |
| 005XXCE-XL | Height 56.25 in | In distribution |
| 005XP-L | Height 52.5 in | In distribution |
| 005XEAK-3XL | Height 58.25 in | In distribution |
| 005XXCA-L | Width 25 in | In distribution |
| 005XEAE-XS | Width 19 in | In distribution |
| 005XXCA-2XL | Width 25 in | In distribution |
| 005XFAO-XL | Height 56.25 in | In distribution |
| 005XE-L | Width 25 in | In distribution |
| 005XFAH-4XL | Height 57.25 in | In distribution |
| 005XXBN-L | Height 55.25 in | In distribution |
| 005XXAE-3XL | Height 58.25 in | In distribution |
| 005XFAO-2XL | Height 57.25 in | In distribution |
| 005XXAE-M | Height 54.25 in | In distribution |
| 005XF-4XL | Width 21 in | In distribution |
| 005XXAE-XL | Height 56.25 in | In distribution |
| 005XXCB-L | Width 25 in | In distribution |
| 005XEAB-2XL | Height 57.25 in | In distribution |
| 005XEAJ-4XL | Height 59.25 in | In distribution |
| 005XEAE-S | Height 53.25 in | In distribution |
| 005XEAC-L | Height 55.25 in | In distribution |
| 005XFAP-M | Height 54.25 in | In distribution |
| 005XEAG-2XL | Height 57.25 in | In distribution |
| 005XEAE-L | Height 55.25 in | In distribution |
| 005XXCB-XL | Width 25 in | In distribution |
| 005XXAE-S | Height 53.25 in | In distribution |
| 005XEAE-4XL | Height 58.25 in | In distribution |
| 005XXCE-L | Height 55.25 in | In distribution |
| 005XEAM-XL | Height 59.5 in | In distribution |
| 005XXCE-M | Height 54.25 in | In distribution |
| 005XXAE-2XL | Height 57.25 in | In distribution |
| 005XPAB-M | Height 52 in | In distribution |
| 005XH-2XL | Height 53.5 in | In distribution |
| 005XEAC-M | Height 54.25 in | In distribution |
| 005XFAH-3XL | Height 57.25 in | In distribution |
| 005XH-XS | Width 21.5 in | In distribution |
| 005XEAK-L | Height 55.25 in | In distribution |
| 005XFAN-2XL | Height 57.25 in | In distribution |
| 005XFAE-2XL | Height 57.25 in | In distribution |
| 005XFAH-XL | Height 57.25 in | In distribution |
| 005XEAE-2XL | Height 57.25 in | In distribution |
| 005XFAN-XL | Height 56.25 in | In distribution |
| 005XXCE-2XL | Height 57.25 in | In distribution |
| 005XE-2XL | Width 29 in | In distribution |
| 005ABAL-M | Width 25 in | In distribution |
| 005XFAB-M | Height 54.25 in | In distribution |
| 005XEAE-XL | Height 56.25 in | In distribution |
| 005XF-M | Width 21 in | In distribution |
| 005XH-S | Height 49.5 in | In distribution |
| 005XEAB-L | Height 55.25 in | In distribution |
| 005XFAN-L | Height 54.25 in | In distribution |
| 005XX-XL | Height 56.25 in | In distribution |
| 005XFAN-M | Height 54.25 in | In distribution |
| 005XEAA-M | Width 23 in | In distribution |
| 005XFAE-XL | Height 56.25 in | In distribution |
| 005ABAM-S | Width 25 in | In distribution |
| 005XFAP-L | Height 55.25 in | In distribution |
| 005ABAL-XL | Width 25 in | In distribution |
| 005XE-XS | Height 51.25 in | In distribution |
| 005XFAO-M | Height 54.25 in | In distribution |
| 005XEAK-M | Height 54.25 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 453 |
| Halyard | O&M Halyard, Inc. | 248 |
| Novo Health Services, LLC | Novo Health Services, LLC | 222 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 214 |
| Convertors | Cardinal Health 200, LLC | 184 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 126 |
| Exact Medical Manufacturing, Inc. | Exact Medical Manufacturing, Inc. | 107 |
| ComPel Surgical Gown | Standard Textile Co., Inc. | 67 |
| Halyard | GRI Medical & Electronic Technology Co., Ltd. | 55 |
| ComPel MLR Surgical Gown | Standard Textile Co., Inc. | 38 |
| Medline Industries, Inc. | Medline Industries, Inc. | 35 |
| Cardinal Health | Cardinal Health 200, LLC | 35 |
Showing 12 of 172. All products under Gown, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K092344 | 2009-12-17 |
| K061491 | 2006-08-09 |
| K032631 | 2004-02-05 |
| K030536 | 2003-05-06 |
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.