결정일2021-12-24
제품 코드LZA
자문 위원회HO
결정Substantially Equivalent
기기 요약
Nitrile Examination Golves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Standard Health Co.,Ltd. It received FDA 510(k) clearance on 2021-12-24 under 510(k) number K212921. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
자주 묻는 질문
What is the Nitrile Examination Golves Powder Free?
Nitrile Examination Golves Powder Free is a medical device that received FDA 510(k) clearance on 2021-12-24. The listed applicant is Jiangsu Standard Health Co.,Ltd. The 510(k) number is K212921.
When did Nitrile Examination Golves Powder Free receive FDA 510(k) clearance?
Nitrile Examination Golves Powder Free received FDA 510(k) clearance on 2021-12-24, under 510(k) number K212921.
Who is the listed applicant for Nitrile Examination Golves Powder Free?
The FDA 510(k) record lists Jiangsu Standard Health Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Nitrile Examination Golves Powder Free?
The FDA product code for Nitrile Examination Golves Powder Free is LZA.
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: LZA)
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.
K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealthK260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.
공식 출처
FDA 데이터베이스에서 보기 →FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.