510(k) K160928
- Device
- Latex Polymer Coated Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove (Gr
- Applicant
- HARTALEGA SDB. BHD.
- 510(k) number
- K160928
- Product code
- KGO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-12-20
- Date received
- 2016-04-04
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KUAN KAM HON
- Address
- Dataran Sd Pju9 Bandar Sri Damansara MY 52200 52200
FDA Registration Numbers#
- 3026746670
- 3001970230
- 3010131137
- 3012421607
- 8041005
- 9616088
- 3018299689
- 3021915797
- 1061124
- 3012304897
- 3006552561
- 3011088743
- 3002806603
- 3004450493
- 3016904853
- 3018507299
- 3010419931
- 3010605427
- 3015997711
- 9611959
- 3007478974
- 3012050423
- 9615978
- 3014269027
- 3005187671
- 2648727
- 3001124136
- 3008266585
- 3009538921
- 3014579161
- 8041003
- 3009337401
- 8040614
- 9617444
- 3034669683
- 3013298431
- 3029901632
- 3027977504
- 3010273867
- 3027157158
- 9680710
- 3011944170
- 3030733800
- 1417592
- 3004122598
- 3010175289
- 3026317063
- 3010966951
- 8040818
- 1649518
- 3030172764
- 3012441043
- 3012354669
- 2032112
- 3043226252
- 3013517171
- 3013557562
- 3016413634
- 9613910
- 3011209798
- 3003744503
- 3009229300
- 8022899
- 9616501
- 3011689956
- 3010602489
- 1833700
- 1055236
- 2939388
- 2029015
- 3012341425
- 3007344957
- 8041180
- 3023143119
- 3003699698
- 2026990
- 3012104670
- 3016785252
- 3012551999
- 8043142
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 |
Legacy Summary#
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FDA Review#
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