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FDA 510(k)

DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE

K-Number: K001611 · 2000-06-30

ApplicantShanghai PT Plastics Enterprise Company, Ltd.
Decision Date2000-06-30
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai PT Plastics Enterprise Company, Ltd.. It received FDA 510(k) clearance on 2000-06-30 under 510(k) number K001611. 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 DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE?

DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE is a medical device that received FDA 510(k) clearance on 2000-06-30. The listed applicant is Shanghai PT Plastics Enterprise Company, Ltd.. The 510(k) number is K001611.

When did DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE receive FDA 510(k) clearance?

DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE received FDA 510(k) clearance on 2000-06-30, under 510(k) number K001611.

Who is the listed applicant for DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE?

The FDA 510(k) record lists Shanghai PT Plastics Enterprise Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE?

The FDA product code for DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE 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 Shanghai PT Plastics Enterprise Company, 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.

K022087DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLORK002870DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLORK001601DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVESK961521PATIENT EXAMINATION GLOVEK963751PT SYNTHETIC MEDICAL GLOVES, POWDER FREE

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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