Primed
Overhead Poly-Coated Gown, Thumbloop with Elastic Cuff , Open Back, Universal, Yellow
109manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Hubei (28), Jiangsu (25), Zhejiang (10). 32 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Xiantao Rayxin Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 18 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Lianyungang Bronson Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 16 |
| Lianyungang Anson Non-woven Product Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 13 |
| Wuhan Huaxin Nonwoven Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 13 |
Showing 12 of 109. All 109 manufacturers in China registered for Gown, Examination
Record
| Listed by | Primed Medical Products Inc., Canada |
|---|---|
| FDA product code | FME |
| Device type | Gown, Examination |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6265 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-07-21 |
| Record revised | 2026-07-14 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in cool, dry, and well ventilated space out of direct sunlight. |
| Packaging | Case of 10, case of 6, case of 5 |
| Distribution end date | 2026-07-22 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PM4-67194XL | 10 | In distribution | |
| PM4-88335XL | 15 | In distribution | |
| PM4-88335 | 20 | In distribution | |
| PM4-27370XL | 10 | In distribution | |
| PM4-67194 | 10 | In distribution | |
| PM4-27370 | 10 | In distribution | |
| PM4-67364 | 10 | Withdrawn | |
| PM4-77365 | 10 | Withdrawn | |
| PM4-88335C | 20 | Withdrawn | |
| PM4-58895 | 10 | Withdrawn | |
| PM4-57372C | 10 | Withdrawn | |
| PM4-77995 | 10 | Withdrawn | |
| PM4-47370 | 10 | Withdrawn | |
| PM4-47370XL | 10 | Withdrawn | |
| PM4-66995 | 10 | Withdrawn | |
| PM4-77365XL | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Encompass | Encompass Group, L.L.C. | 97 |
| Defend | Young Mydent, LLC | 54 |
| JMU | JMU Dental, Inc | 40 |
| Mammogram Jacket | Standard Textile Co., Inc. | 38 |
| Patient Gown | Standard Textile Co., Inc. | 33 |
| Mammogram Cape | Standard Textile Co., Inc. | 20 |
| ThermalX | Adroit Medical Systems, Inc. | 18 |
| Thermoflect | Encompass Group, L.L.C. | 18 |
| MARK3 | Cargus International, Inc | 17 |
| Vivit Supply | Vivit Supply LLC | 14 |
| Precept® | Precept Medical Products, Inc. | 13 |
| Mammogram Robe | Standard Textile Co., Inc. | 13 |
Showing 12 of 75. All products under Gown, Examination
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.