FDA 510(k)

SANCARE 무균 레이저 검사 장갑 (GLOVTEK 무균 레이저 검사 장갑로도 판매됨)

K-번호: K171367 · 2018-01-26

결정일2018-01-26

제품 코드LYY

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) is the device name listed in this FDA 510(k) record. The listed applicant is Sanrea Healthcare Products Pvt, Ltd.. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K171367. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)?

SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Sanrea Healthcare Products Pvt, Ltd.. The 510(k) number is K171367.

When did SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) receive FDA 510(k) clearance?

SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) received FDA 510(k) clearance on 2018-01-26, under 510(k) number K171367.

Who is the listed applicant for SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)?

The FDA 510(k) record lists Sanrea Healthcare Products Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)?

The FDA product code for SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) is LYY.

Sanrea Healthcare Products Pvt, Ltd.를 신청인으로 등재한 기타 기록

K171550정화된 레이저 수술 장갑, 파우더 프리 K171093정화된 니트릴 환자 검사 장갑, 파우더 프리

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