Hongxin
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED), Model: S
72manufacturers in China registered for this device type
4catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (26), Hebei (12), Anhui (6). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Copious Intl., Inc. | Heyuan, Guangdong Province | Contract manufacturer | 11 | |
| Grand Work Plastic Products Co., Ltd. | Zanhuang | Hebei | Contract manufacturer | 5 |
| Shanxi Hongjin Plastic Technology Co., Ltd. | Linfen | Shanxi | Contract manufacturer | 5 |
| Anhui Intco Medical Products Co., Ltd. | Huaibei | Anhui | Contract manufacturer | 5 |
| YUE Kang Anhui Medical Products Co., Ltd. | Huaibei | Anhui | Contract manufacturer | 5 |
| Opus Gloves Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Zhongnuo Medical Products Co., Ltd. | Tangshan | Hebei | Contract manufacturer | 3 |
| Ever Shine Plastic Technology Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 2 |
| Jiangsu Huayuan Medical Technology Co., Ltd. | Dongtai | Jiangsu | Contract manufacturer | 1 |
| Anhui Hongyuan Medical Products Co., Ltd. | Huaibei | Anhui | Contract manufacturer | 1 |
| Wuhan Hongjian Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 1 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
Showing 12 of 72. All 72 manufacturers in China registered for Vinyl Patient Examination Glove
Record
| Listed by | Shandong Hongxin Chemicals Co., Ltd., China |
|---|---|
| FDA product code | LYZ |
| Device type | Vinyl Patient Examination Glove |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6250 |
| Record published | 2022-09-05 |
| Record revised | 2023-01-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VINYL | In distribution | |
| VINYL | In distribution | |
| VINYL | In distribution | |
| VINYL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 48 |
| Ammex Professional | Ammex Corporation | 43 |
| Basic | Intco Medical Industries, Inc. | 38 |
| Schneider | Avatech Corp. | 36 |
| WellBefore | Social Medical Supply, LLC | 28 |
| SafeHealth | PM Gloves U S A Inc | 24 |
| PremierPro | Prestige Ameritech | 24 |
| Basic | Basic Medical Technology Inc. | 22 |
| ProCure | Twin Med, LLC | 21 |
| FifthPulse | Jeg & Sons Inc. | 21 |
| Tronex International, Inc. | Tronex International, Inc. | 20 |
| McKesson | Mckesson Medical-Surgical Inc. | 19 |
Showing 12 of 177. All products under Vinyl Patient Examination Glove
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212488 | 2021-11-26 |
| K122828 | 2012-12-10 |
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.