510(k) K003872
- Device
- GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
- Applicant
- Guthrie Medicare Products (Melaka) Sdn Bhd
- 510(k) number
- K003872
- Product code
- LYY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-01-23
- Date received
- 2000-12-15
- 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
- N
Applicant Contact#
- Contact
- SUSAN D GOLDSTEIN-FALK
- Address
- 55 Northern Blvd., Suite 200 Great Neck NY US 11021 11021
FDA Registration Numbers#
- 1119294
- 3019849096
- 3038718579
- 2132509
- 3015128453
- 8040936
- 3005568780
- 1250045
- 2024980
- 3019585047
- 3017940518
- 3005024094
- 3005558160
- 3010363542
- 3005632797
- 3007707004
- 2084709
- 9681660
- 9616501
- 3011427127
- 3004553390
- 8043848
- 3011209798
- 8041150
- 3010131137
- 3011658061
- 3011391433
- 9615978
- 3019798835
- 3004967282
- 3012446547
- 3007842555
- 3021206557
- 3012441043
- 8040614
- 3014384460
- 3021595900
- 1221744
- 3016844398
- 3010220595
- 3003699698
- 2954902
- 8041003
- 2437780
- 9615095
- 1043549
- 8040818
- 9680710
- 3004939660
- 3009474977
- 3008509176
- 3009964047
- 3023272672
- 3006796582
- 3010175289
- 1928237
- 1219103
- 3020521811
- 3042956952
- 3014164734
- 3007421906
- 9617439
- 3012421607
- 9680466
- 3012104670
- 2087418
- 1000266564
- 2939388
- 3006552561
- 9613494
- 3013530281
- 1000254914
- 9615905
- 3007471500
- 3030733800
- 3003851058
- 3014269027
- 3017929385
- 3016785252
- 8043736
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 |