Disposable, vinyl examination gloves, Yellow
FDA 510(k) clearance K220055 · decided 2022-08-25
Clearance details
- K-number
- K220055
- Device name
- Disposable, vinyl examination gloves, Yellow
- Applicant
- Dezhou Hengchang Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-01-06
- Decision date
- 2022-08-25
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- LYZ
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Dezhou City, CN
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) (K260860) | Basic Medical Technology, Inc. | 2026-04-07 |
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| Disposable Powder Free Vinyl Examination Gloves, Beige/Clear (K221980) | Ever Global (Vietnam) Enterprise Corporation | 2023-02-06 |
| Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple (K220992) | Ever Global (Vietnam) Enterprise Corporation | 2022-10-19 |
| Disposable Vinyl Examination Gloves (K223008) | Jiangxi Handspro Products Solutions Co., Ltd. | 2022-10-08 |
| DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) (K222442) | Anhui Bytech Medical Supplies Co., Ltd. | 2022-09-28 |
| Disposable Vinyl Examination Glove (K220469) | Chifeng Huawei Medical Science&Technology Co., Ltd. | 2022-06-16 |
| Vinyl Co-Polymer Powder-free Examination Gloves, Black (K220240) | Grand Work Plastic Products Co., Ltd. | 2022-03-31 |
| Vinyl/Nitrile Blend Exam Glove (K213634) | Dezhou Hengchang Medical Technology Co., Ltd. | 2022-02-18 |
Recalls involving this device
No recalls on record reference this clearance.