510(k) K121335
- Device
- G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE
- Applicant
- HUTCHINSON SANTE S.N.C.
- 510(k) number
- K121335
- Product code
- KGO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-09-13
- Date received
- 2012-05-03
- Regulation
- 878.4460
- Classification name
- Surgeon's Gloves
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAFFI KRIKORIAN
- Address
- Rue Marret Paturel Liancourt FR F-60140 F-60140
FDA Registration Numbers#
- 3004967282
- 3012050423
- 3015173212
- 1423537
- 3016785252
- 3023143119
- 3009229300
- 3006552561
- 3034669683
- 3007289408
- 3011088743
- 8022899
- 1833700
- 3014269027
- 3006796582
- 3015997711
- 3010309112
- 8041150
- 8043736
- 9613910
- 2032112
- 9616088
- 9613662
- 3010966951
- 3009538921
- 1319639
- 3042894943
- 1054241
- 3005022483
- 9610406
- 3012354669
- 3016413634
- 8041180
- 3002807090
- 3001970230
- 3043051314
- 1018470
- 2024351
- 3018299689
- 9611959
- 3025355668
- 3010220595
- 3027157158
- 3012551999
- 3003199637
- 9615914
- 2029015
- 3008253024
- 1921846
- 8043142
- 8043848
- 3021192208
- 3024706752
- 1055236
- 3023339256
- 3010419931
- 3004111573
- 3021915797
- 3010436932
- 3004450493
- 3007344957
- 3014164734
- 3026317063
- 1643817
- 8040818
- 1649518
- 3009337401
- 3019769825
- 3003699698
- 9680710
- 1061124
- 3043226252
- 8041003
- 3035455506
- 3008266585
- 3010602489
- 3008062466
- 3010187826
- 3017616393
Source Documents#
Other 510(k) Records For Product Code KGO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253060 | Sterile Latex Powder Free Surgical Gloves | Protect Gloves Company Limited | 2026-05-22 |
| K250313 | Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid | Harps Europe Manufacturing GmbH | 2025-08-19 |
| K240790 | Polyisoprene Surgical gloves | Suzhou Colour-Way New Material Co., Ltd. | 2024-08-23 |
| K232079 | Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | Wrp Asia Pacific Sdn. Bhd. | 2024-03-28 |
| K232444 | Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. | 2023-12-20 |
| K231902 | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) | Ansell Healthcare | 2023-10-20 |
| K231973 | PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove | Ineo Tech Sdn Bhd | 2023-09-29 |
| K231446 | Single-Use Latex Sterile Surgical Gloves (SG100) | Fitone Latex Products Co., Ltd. Guangdong | 2023-09-22 |
| K230578 | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | Wrp Asia Pacific Sdn. Bhd. | 2023-08-31 |
| K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential | Ansell Healthcare Products, LLC | 2023-08-23 |
| K222993 | Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs | Sentienx Sdn Bhd | 2023-08-18 |
| K230832 | Powdered Free Sterile Natural Rubber Latex Surgical Gloves | The Egyptian Company For Medical & Electronic Industries | 2023-08-16 |
| K230304 | Polyisoprene Surgical Gloves | Puyang Linshi Medical Supplies Co., Ltd. | 2023-08-09 |
| K213289 | Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs | Ansell Healthcare Products, LLC | 2023-05-26 |
| K230217 | Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. | 2023-05-13 |
Legacy Summary#
summary
FDA Review#
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