510(k) K091421
- Device
- NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED)
- Applicant
- Novapro Co., Ltd.
- 510(k) number
- K091421
- Product code
- LYZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-07-23
- Date received
- 2009-05-13
- 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
- ZHENZHONG CHENG
- Address
- # 21 Qingtian Rd. Lot 4 Zibo, Shandong CN 255414 255414
FDA Registration Numbers#
- 3005060582
- 1319302
- 2083656
- 3009099927
- 9681151
- 3016844398
- 3004134948
- 3008388240
- 3014268334
- 3007289408
- 3009218271
- 3017940518
- 3007392007
- 3030470903
- 3005761322
- 3030692786
- 1833700
- 3002801783
- 3015477649
- 3011586620
- 3016601021
- 3007838093
- 3008191396
- 3002714597
- 3009055041
- 3013998568
- 3011427127
- 3010287987
- 3004950768
- 3007307589
- 1054241
- 3015537296
- 3017610877
- 1928237
- 3006946173
- 3013514660
- 3009233038
- 3005558160
- 3005460813
- 2939935
- 3008261717
- 9614306
- 3020106122
- 3034618336
- 9611959
- 3013565389
- 3003199637
- 3021286079
- 2029015
- 2517925
- 3013496867
- 2024980
- 3031181949
- 1055236
- 3042129350
- 3009709178
- 3015412466
- 3009243435
- 3005596481
- 3004150701
- 1313700
- 3004168786
- 3015128453
- 3011862887
- 3009549523
- 3010363542
- 3011786252
- 3006789222
- 3007707004
- 3027601983
- 3005012805
- 3029952429
- 1038758
- 3004993527
- 3010582952
- 3029901632
- 3007842555
- 3007502227
- 3007220726
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 |