510(k) K211620
- Device
- Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black And Green Colors With Protein Content Labeling Claim (50 Micrograms Or Less)
- Applicant
- Shen Wei USA Inc.
- 510(k) number
- K211620
- Product code
- LYY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-08-19
- Date received
- 2021-05-26
- Regulation
- 880.6250
- Classification name
- Latex 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#
- 9617439
- 3004967282
- 3012050423
- 3016785252
- 1423537
- 1319302
- 3009229300
- 3006552561
- 9680466
- 9613998
- 3021206557
- 1219103
- 3016844398
- 2954902
- 3019585047
- 3021394840
- 3004553390
- 3017940518
- 3030692786
- 1000266564
- 3017929385
- 8040880
- 3015219124
- 3014269027
- 3005568780
- 3008604557
- 3006796582
- 3005632797
- 3015997711
- 3010309112
- 8041150
- 3007471500
- 8043736
- 3009055041
- 3009538921
- 3011427127
- 1928237
- 3019798835
- 3023272672
- 3005558160
- 2939935
- 3007421906
- 3012924721
- 1220477
- 3010220595
- 3011658061
- 3012429634
- 3003199637
- 9681163
- 2132509
- 3008253024
- 3015729128
- 8043142
- 8043848
- 3021192208
- 2024980
- 3038718579
- 3010436932
- 3010864832
- 3042956952
- 2084709
- 8041120
- 3014164734
- 8040936
- 3015128453
- 8040818
- 3019769825
- 3003699698
- 3008509176
- 3010363542
- 9680710
- 3007707004
- 8041003
- 3035455506
- 3010602489
- 3008107579
- 3003851058
- 3009474977
- 3007842555
- 3007502227
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LYY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250069 | Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein | Comfort Rubber Gloves Industries Sdn. Bhd. | 2025-04-29 |
| K240266 | Latex Examination Glove Powder Free (Ocean Blue and Natural White) | Sri Trang Gloves (Thailand) Public Company Limited | 2024-09-09 |
| K230573 | Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) | Kossan International Sdn Bhd | 2023-06-13 |
| K223298 | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) | Shandong Intco Medical Products Co, Ltd. | 2023-02-22 |
| K222612 | Powder-Free Latex examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022-11-25 |
| K221667 | Non Sterile Powder Free Latex Examination Glove | New Era Medicare Sdn. Bhd. | 2022-10-28 |
| K222348 | JR MEDIC | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022-10-27 |
| K221374 | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2022-10-26 |
| K222693 | Single-use medical latex examination gloves (LG100) | Fitone Latex Products Co., Ltd. Guangdong | 2022-09-24 |
| K221648 | Iconic Latex Glove | Iconic Medicare Sdn Bhd | 2022-08-25 |
| K211601 | Powder Free Latex Examination Glove, Non-Sterile | Wrp Asia Pacific Sdn. Bhd. | 2022-08-22 |
| K212482 | Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White | Sri Trang Gloves (Thailand) Public Company Limited | 2022-08-09 |
| K214017 | Examination gloves-Type A(Latex gloves) | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | 2022-07-14 |
| K221185 | TC Gloves | Thanh Cong Pharmaceutical and Trading Company Limited | 2022-06-22 |
| K212597 | Amazing+ Latex Examination Powder Free Gloves | Amazing Rubber Products Pvt, Ltd. | 2022-05-28 |
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