510(k) K992679
- Device
- SURGEON POWDER-FREE GLOVES, LATEX, STERILE
- Applicant
- Wear Safe Malaysia Sdn. Bhd.
- 510(k) number
- K992679
- Product code
- KGO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-10-21
- Date received
- 1999-08-10
- Regulation
- 878.4460
- Classification name
- Surgeon'S Gloves
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CLAUDE COTTET
- Address
- Lot 1, Leboh Hishamuddin Satu, North Klang Straits Ind. Area Port Klang, Selangor, D.E. MY 42000 42000
FDA Registration Numbers#
- 3034669683
- 9680794
- 3005187671
- 9615914
- 3018507299
- 3005595283
- 8041180
- 3004681601
- 1061124
- 3012307300
- 9616501
- 3001970230
- 8043848
- 3013516822
- 8041150
- 3010131137
- 3011209798
- 3015173212
- 2026990
- 9615978
- 3004111573
- 3004967282
- 3012441043
- 8040614
- 3014384460
- 3042894943
- 3010220595
- 3001124136
- 3003699698
- 3025413681
- 1054241
- 8041003
- 3025355668
- 3026317063
- 9613910
- 8040818
- 3029901632
- 9680710
- 3012551999
- 3008266585
- 3006796582
- 3010966951
- 3010175289
- 3020521811
- 3007344957
- 3010273867
- 2024351
- 3027977504
- 3002807090
- 3014164734
- 1833700
- 3043226252
- 1319639
- 3010419931
- 9613662
- 1018470
- 1043214
- 3012421607
- 3012104670
- 9614502
- 2939388
- 3006552561
- 3027157158
- 3013530281
- 3007478974
- 3002806603
- 3005022483
- 3030733800
- 3014269027
- 1921846
- 3021915797
- 3016785252
- 8043736
- 3013557562
- 3011689956
- 3016904853
- 3021192208
- 3008253024
- 3024706752
Source Documents#
510(k) summary PDF not indicated by FDA
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 |