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FDA 510(k)

POWDER-FREE VINYL EXAM GLOVE, YELLOW

K-Number: K011413 · 2001-06-05

ApplicantHeyuan Hongli Industries, Inc.
Decision Date2001-06-05
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER-FREE VINYL EXAM GLOVE, YELLOW is the device name listed in this FDA 510(k) record. The listed applicant is Heyuan Hongli Industries, Inc.. It received FDA 510(k) clearance on 2001-06-05 under 510(k) number K011413. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWDER-FREE VINYL EXAM GLOVE, YELLOW?

POWDER-FREE VINYL EXAM GLOVE, YELLOW is a medical device that received FDA 510(k) clearance on 2001-06-05. The listed applicant is Heyuan Hongli Industries, Inc.. The 510(k) number is K011413.

When did POWDER-FREE VINYL EXAM GLOVE, YELLOW receive FDA 510(k) clearance?

POWDER-FREE VINYL EXAM GLOVE, YELLOW received FDA 510(k) clearance on 2001-06-05, under 510(k) number K011413.

Who is the listed applicant for POWDER-FREE VINYL EXAM GLOVE, YELLOW?

The FDA 510(k) record lists Heyuan Hongli Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER-FREE VINYL EXAM GLOVE, YELLOW?

The FDA product code for POWDER-FREE VINYL EXAM GLOVE, YELLOW is LYZ.

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Other records listing Heyuan Hongli Industries, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K030997POWDERED VINYL EXAM GLOVES, WHITEK022305MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITEK011414POWDERED VINAL EXAM GLOVESK011412POWDER-FREE VINYL EXAM GLOVES

Related Devices (Code: LYZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation

Official Source

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