510(k) K213144
- Device
- Biodegradable Powder Free Vinyl Examination Gloves Blue, Green And White Colors
- Applicant
- Shen Wei USA Inc.
- 510(k) number
- K213144
- Product code
- LYZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-22
- Date received
- 2021-09-27
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Cheryl Reep
- Address
- 33278 Central Ave. Suite 102 Union City CA US 94587 94587
FDA Registration Numbers#
- 1119294
- 3015128453
- 3013998568
- 3004150701
- 3015537296
- 1250045
- 3009218271
- 2024980
- 3009549523
- 3017940518
- 3005558160
- 3008771621
- 3010363542
- 3007707004
- 3009211686
- 3011427127
- 3007307589
- 3016601021
- 3010287987
- 3020106122
- 3018108902
- 3011209798
- 3011391433
- 3004134948
- 3004993527
- 3007842555
- 3013565389
- 3011862887
- 3016844398
- 3014345238
- 3004704697
- 3037028694
- 1054241
- 3015477649
- 1038758
- 3008388240
- 3009118264
- 3029901632
- 3007392007
- 3013514660
- 1313700
- 1928237
- 1833700
- 3015875006
- 3011586620
- 1043214
- 3012421607
- 3003364331
- 3009512322
- 3008261717
- 3011089435
- 3012711490
- 3002801783
- 2939388
- 3013496867
- 3030682048
- 3031181949
- 9681151
- 3008191396
- 3027601983
- 3010582952
- 3002714597
- 3005012805
- 3005460813
- 3013557562
- 1055236
- 3006787036
- 2435946
- 3009709178
- 3009055041
- 3004950768
- 3009243435
- 3003896660
- 2938651
- 1417592
- 3013576504
- 3011238790
- 3004168786
- 2083656
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K241252 | Disposable Vinyl Examination Gloves | Anqing Pukang Medical Technology Co., Ltd. | 2024-05-20 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases