POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)— 510(k) K120968

Name: FDA 510(k) clearance K120968
Creator: U.S. Food and Drug Administration
Published: 2012-09-19

Substantially Equivalent

Tangshan Zhonghong Pulin Plastic Co.,Ltd

FDA 510(k) clearance K120968 for POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED), Substantially Equivalent on 2012-09-19. Applicant: Tangshan Zhonghong Pulin Plastic Co.,Ltd. Device class: 1.

Clearance details

Applicant: Tangshan Zhonghong Pulin Plastic Co.,Ltd
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2012-03-30
Decision date: 2012-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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Recalls naming K120968

K-number listed on FDA's recall record

Z-0741-2017 — McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140Class II·Terminated·CYPRESS MEDICAL PRODUCTS·20161012

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120968.

Data sourced from openFDA. This site is unofficial and independent of the FDA.