510(k) K210799
- Device
- Powder Free Vinyl Patient Examination Gloves
- Applicant
- Yunnan Huazhiyuan Medical Technology Co., Ltd.
- 510(k) number
- K210799
- Product code
- LYZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-05-14
- Date received
- 2021-03-16
- 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
- No
Applicant Contact#
- Contact
- Yun Gao
- Address
- Yangjie Industrial Park,Jianshui County Honghe Hani And Yi Autonomous Prefecture CN 654300 654300
FDA Registration Numbers#
- 3007307589
- 2939388
- 3002801783
- 3011586620
- 3012314549
- 3013557562
- 3007707004
- 1038758
- 9614306
- 3005012805
- 3007842555
- 3007407626
- 3004950768
- 3013998568
- 3014268334
- 3012317628
- 3014345238
- 3007502227
- 3005460813
- 3008261717
- 9681151
- 3007220726
- 3015875006
- 3011208584
- 3017953728
- 3012421607
- 2938651
- 3014421917
- 3030692786
- 3008771621
- 3021286079
- 3009549523
- 3009512322
- 3010287987
- 3004993527
- 3045079147
- 3029952428
- 3005060582
- 3013565389
- 3012304513
- 3006946173
- 3015745029
- 3003529075
- 3009496643
- 1313700
- 3031181949
- 3008808082
- 1043214
- 1250045
- 3017610877
- 3020677870
- 2517925
- 3030682048
- 1055236
- 3015412466
- 3018108902
- 3007838093
- 3009211686
- 3015537296
- 3013496867
- 3017940518
- 3003364331
- 3016601021
- 3005596481
- 3030470903
- 3006789222
- 2024980
- 3020106122
- 3002714597
- 3003199637
- 3009218271
- 2648727
- 2939935
- 3034618336
- 3037028694
- 1119294
- 3004150701
- 3009233038
- 3029952429
- 3029901632
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 |
| 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#
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
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