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FDA 510(k)

PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES

K-Number: K042213 · 2004-09-09

ApplicantShandong Perfect Plastic Co., Ltd.
Decision Date2004-09-09
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Perfect Plastic Co., Ltd.. It received FDA 510(k) clearance on 2004-09-09 under 510(k) number K042213. 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 NON-STERILE VINYL EXAMINATION GLOVES?

PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2004-09-09. The listed applicant is Shandong Perfect Plastic Co., Ltd.. The 510(k) number is K042213.

When did PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES receive FDA 510(k) clearance?

PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES received FDA 510(k) clearance on 2004-09-09, under 510(k) number K042213.

Who is the listed applicant for PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES?

The FDA 510(k) record lists Shandong Perfect Plastic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES?

The FDA product code for PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES is LYZ.

Related Clinical Trials

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.

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Other records listing Shandong Perfect Plastic 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.

K042214POWDER-FREE NON-STERILE VINYL EXAMINATION 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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