Exact Medical Manufacturing, Inc.
Cover, Back Table, 110x112cm PSB (Absorbent Reinforcement) – 60x112 cm
68manufacturers in China registered for this device type
107catalogue numbers in this listing
3510(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 | Exact Medical Manufacturing, Inc., China |
|---|---|
| FDA product code | FYA |
| Device type | Gown, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K111535 |
| Record published | 2026-05-19 |
| Record revised | 2024-10-02 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case of 28, case of 36, case of 32, case of 44, case of 50, case of 60 |
| Distribution end date | 2024-10-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DEF5940 | In distribution | |
| E100360 | In distribution | |
| EU000350 | In distribution | |
| DEF5943 | In distribution | |
| E105260-Qmedic | In distribution | |
| EU000360 | In distribution | |
| DEF5945 | In distribution | |
| EU000150 | In distribution | |
| 2110-VET | In distribution | |
| E100370 | In distribution | |
| 2105 | In distribution | |
| EU000160 | In distribution | |
| DEF5947 | In distribution | |
| J0738 | In distribution | |
| DEF5944 | In distribution | |
| EU002150 | In distribution | |
| DEF5942 | In distribution | |
| J0738L | In distribution | |
| DEF5946 | In distribution | |
| DEF5941 | In distribution | |
| E105250-Qmedic | In distribution | |
| 50331 | Withdrawn | |
| E104470 | Withdrawn | |
| SH34 | Withdrawn | |
| E100350 | Withdrawn | |
| E103170 | Withdrawn | |
| 10121 | Withdrawn | |
| E100140N | Withdrawn | |
| E104060 | Withdrawn | |
| E104160PS | Withdrawn | |
| 10321 | Withdrawn | |
| E4302 | Withdrawn | |
| 70131 | Withdrawn | |
| 00401 | Withdrawn | |
| 40141 | Withdrawn | |
| E100150N | Withdrawn | |
| SB-Toga-XL-EL | Withdrawn | |
| 10231 | Withdrawn | |
| 10221 | Withdrawn | |
| E104070 | Withdrawn | |
| 00403 | Withdrawn | |
| SF-4L-EL | Withdrawn | |
| E313101 | Withdrawn | |
| E100360N | Withdrawn | |
| E5101N | Withdrawn | |
| 40131 | Withdrawn | |
| E2009 | Withdrawn | |
| E100370 | Withdrawn | |
| E100340N | Withdrawn | |
| E4301 | Withdrawn | |
| E5107N | Withdrawn | |
| 10331 | Withdrawn | |
| E5103N | Withdrawn | |
| E5104N | Withdrawn | |
| 70121 | Withdrawn | |
| E10115A0 | Withdrawn | |
| E5106N | Withdrawn | |
| 10241 | Withdrawn | |
| E100350N | Withdrawn | |
| 10141 | Withdrawn | |
| E2705 | Withdrawn | |
| 10601006 | Withdrawn | |
| E10116A0 | Withdrawn | |
| E105250 | Withdrawn | |
| 00403 | Withdrawn | |
| E100330N | Withdrawn | |
| E100360 | Withdrawn | |
| SH35 | Withdrawn | |
| 50321 | Withdrawn | |
| 2105 | Withdrawn | |
| E105260 | Withdrawn | |
| E202102N-1 | Withdrawn | |
| E104170S | Withdrawn | |
| E104460 | Withdrawn | |
| E100160N | Withdrawn | |
| SF-3PXXXLB | Withdrawn | |
| 50351A | Withdrawn | |
| E105170 | Withdrawn | |
| E100130N | Withdrawn | |
| E105150 | Withdrawn | |
| E5102N | Withdrawn | |
| E105270 | Withdrawn | |
| E5105N | Withdrawn | |
| 2110 | Withdrawn | |
| E104450 | Withdrawn | |
| E104050 | Withdrawn | |
| E6552N | Withdrawn | |
| E5200N | Withdrawn | |
| 50341 | Withdrawn | |
| 40151A | Withdrawn | |
| E10136A0 | Withdrawn | |
| E4300 | Withdrawn | |
| E108140N | Withdrawn | |
| E10117A0 | Withdrawn | |
| MPR-70287 | Withdrawn | |
| 10131 | Withdrawn | |
| E5108N | Withdrawn | |
| 00402 | Withdrawn | |
| E6551N | Withdrawn | |
| E10137A0 | Withdrawn | |
| E10137A2 | Withdrawn | |
| E105160 | Withdrawn | |
| 10341 | Withdrawn | |
| 40121 | Withdrawn | |
| E103150 | Withdrawn | |
| E108130N | Withdrawn | |
| E103160 | Withdrawn |
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 |
| Lac-Mac | LAC-MAC Limited | 157 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 126 |
| 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 |
|---|---|
| K120045 | 2012-06-12 |
| K111535 | 2011-08-26 |
| K101593 | 2010-09-03 |
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.