510(k) K230304

Device: Polyisoprene Surgical Gloves
Applicant: Puyang Linshi Medical Supplies Co., Ltd.
510(k) number: K230304
Product code: KGO
Decision: Substantially Equivalent (SESE)
Decision date: 2023-08-09
Date received: 2023-02-03
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: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Catherine Liu
Address: East Of Panjin Rd. And N. Of Fumin Rd. In Puyang County Puyang CN 457001 457001

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

510(k) summary PDF

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
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
K222620	Sterilized Latex Surgical Gloves	Suzhou Colour-Way New Material Co., Ltd.	2023-03-23