결정일2026-05-22
제품 코드KGO
자문 위원회SU
결정Substantially Equivalent
기기 요약
Sterile Latex Powder Free Surgical Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Protect Gloves Company Limited. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K253060. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
자주 묻는 질문
What is the Sterile Latex Powder Free Surgical Gloves?
Sterile Latex Powder Free Surgical Gloves is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Protect Gloves Company Limited. The 510(k) number is K253060.
When did Sterile Latex Powder Free Surgical Gloves receive FDA 510(k) clearance?
Sterile Latex Powder Free Surgical Gloves received FDA 510(k) clearance on 2026-05-22, under 510(k) number K253060.
Who is the listed applicant for Sterile Latex Powder Free Surgical Gloves?
The FDA 510(k) record lists Protect Gloves Company Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sterile Latex Powder Free Surgical Gloves?
The FDA product code for Sterile Latex Powder Free Surgical Gloves is KGO.
관련 임상시험
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
관련 기기 (코드: KGO)
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural 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 FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.K231902GAMMEX 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
공식 출처
FDA 데이터베이스에서 보기 →FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.