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FDA 510(k)

PRE-POWDERED VINYL EXAM GLOVES

K-Number: K042951 · 2005-03-10

ApplicantZibo Hengchang Plastic & Rubber Products Co., Ltd.
Decision Date2005-03-10
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRE-POWDERED VINYL EXAM GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Zibo Hengchang Plastic & Rubber Products Co., Ltd.. It received FDA 510(k) clearance on 2005-03-10 under 510(k) number K042951. 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 PRE-POWDERED VINYL EXAM GLOVES?

PRE-POWDERED VINYL EXAM GLOVES is a medical device that received FDA 510(k) clearance on 2005-03-10. The listed applicant is Zibo Hengchang Plastic & Rubber Products Co., Ltd.. The 510(k) number is K042951.

When did PRE-POWDERED VINYL EXAM GLOVES receive FDA 510(k) clearance?

PRE-POWDERED VINYL EXAM GLOVES received FDA 510(k) clearance on 2005-03-10, under 510(k) number K042951.

Who is the listed applicant for PRE-POWDERED VINYL EXAM GLOVES?

The FDA 510(k) record lists Zibo Hengchang Plastic & Rubber Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRE-POWDERED VINYL EXAM GLOVES?

The FDA product code for PRE-POWDERED VINYL EXAM GLOVES is LYZ.

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Other records listing Zibo Hengchang Plastic & Rubber Products Co., Ltd. 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.

K042952VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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