510(k) K241252
- Device
- Disposable Vinyl Examination Gloves
- Applicant
- Anqing Pukang Medical Technology Co., Ltd.
- 510(k) number
- K241252
- Product code
- LYZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-05-20
- Date received
- 2024-05-03
- Regulation
- 880.6250
- Classification name
- Vinyl Patient Examination Glove
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- Min Gao
- Address
- No 7 Haian Rd. Anqing CN 246000 246000
FDA Registration Numbers#
- 3004993527
- 3014268334
- 3008808082
- 3007307589
- 3011427127
- 3011209798
- 3009233038
- 3012304513
- 3012421607
- 3003896660
- 3030692786
- 3009512322
- 3013557562
- 3030470903
- 3021286079
- 3008840959
- 2939388
- 3007392007
- 3009709178
- 3013576504
- 3010582952
- 3013496867
- 3005024009
- 3009741833
- 3027601983
- 3007502227
- 3045079147
- 3015128453
- 3013998568
- 2083656
- 3017940518
- 3020106122
- 3010287987
- 3005060582
- 3009211686
- 2938651
- 3020677870
- 2029015
- 3011391433
- 3006789222
- 3016844398
- 3015142965
- 3004134948
- 1928237
- 3003529075
- 1038758
- 2939935
- 3008384335
- 3013514660
- 3002714597
- 3007707004
- 3004704697
- 1319302
- 3015477649
- 3011586620
- 3045078803
- 3007838093
- 3003199637
- 3016601021
- 2435946
- 3012314549
- 3015537296
- 2648727
- 3030682048
- 9681151
- 3009218271
- 3004150701
- 3006946173
- 3009055041
- 3007220726
- 3015745029
- 3012711490
- 3005012805
- 9614306
- 3011862887
- 3042129350
- 1119294
- 3010869528
- 3008771621
Source Documents#
Other 510(k) Records For Product Code LYZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260860 | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) | Basic Medical Technology, Inc. | 2026-04-07 |
| K252467 | Disposable Vinyl Examination Gloves | Viet Phu Trade and Import Export Co., Ltd. | 2025-10-27 |
| K252505 | Powder-Free Vinyl Exam Gloves, clear | Basic Medical Technology, Inc. | 2025-08-28 |
| K230046 | Vinyl examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2023-03-25 |
| K221980 | Disposable Powder Free Vinyl Examination Gloves, Beige/Clear | Ever Global (Vietnam) Enterprise Corporation | 2023-02-06 |
| K220992 | Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple | Ever Global (Vietnam) Enterprise Corporation | 2022-10-19 |
| K223008 | Disposable Vinyl Examination Gloves | Jiangxi Handspro Products Solutions Co., Ltd. | 2022-10-08 |
| K222442 | DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) | Anhui Bytech Medical Supplies Co., Ltd. | 2022-09-28 |
| K220055 | Disposable, vinyl examination gloves, Yellow | Dezhou Hengchang Medical Technology Co., Ltd. | 2022-08-25 |
| K220469 | Disposable Vinyl Examination Glove | Chifeng Huawei Medical Science&Technology Co., Ltd. | 2022-06-16 |
| K220240 | Vinyl Co-Polymer Powder-free Examination Gloves, Black | Grand Work Plastic Products Co., Ltd. | 2022-03-31 |
| K213634 | Vinyl/Nitrile Blend Exam Glove | Dezhou Hengchang Medical Technology Co., Ltd. | 2022-02-18 |
| K213625 | Vinyl Examination Gloves | Dezhou Hengchang Medical Technology Co., Ltd. | 2022-02-17 |
| K212011 | Vinyl Powder Free Examination Glove | Top Glove Vietnam Company Limited | 2022-02-14 |
| K213019 | Vinyl Exam Gloves | Hebei Astro Medical Supply Co., Ltd. | 2022-01-05 |