510(k) K221424
- Device
- Sterile Surgical Powder Free Latex Glove
- Applicant
- New Era Medicare Sdn. Bhd.
- 510(k) number
- K221424
- Product code
- KGO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-01-26
- Date received
- 2022-05-16
- 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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Fatin Nor Irdina binti Ahmad Fauzi
- Address
- Plot 2621-2624 Teluk Intan MY 36000 36000
FDA Registration Numbers
- 9616501
- 3013517171
- 3002807090
- 3003529075
- 1061124
- 8041003
- 3019769825
- 8040818
- 3012441043
- 3025413681
- 3023339256
- 3018507299
- 1018470
- 9615978
- 3007478974
- 3027977504
- 3024374107
- 3004450493
- 3015997711
- 2648727
- 3007048057
- 3008253024
- 3001124136
- 3013557562
- 3010131137
- 3010309112
- 9617444
- 3010175289
- 1423537
- 3013530281
- 3012307300
- 3007344957
- 3010273867
- 3013298431
- 3043051314
- 3021192208
- 3012341425
- 3016413634
- 2024351
- 9613910
- 3030733800
- 3011209798
- 2026990
- 3013516822
- 1043214
- 1055236
- 3012421607
- 3035455506
- 1649518
- 3015173212
- 3014384460
- 3010605427
- 3008252486
- 8041150
- 2029015
- 8041005
- 3004967282
- 3008062466
- 9680710
- 3014579161
- 3009229300
- 1417592
- 3042894943
- 3010966951
- 3010436932
- 9680622
- 3005022483
- 3020521811
- 1319639
- 3006796582
- 8041180
- 3009538921
- 8040614
- 8043736
- 3003699698
- 8043142
- 3007289408
- 3008266585
- 3001970230
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
Other 510(k) Records For Product Code KGO
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250313 | Sterile Powder Free Synthetic Rubber Surgeons 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 |
| K222350 | Sterile Nitrile Surgical Gloves Powder Free | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2023-04-13 |