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FDA 510(k)

PATIENT EXAMINATION GLOVE

K-Number: K961521 · 1997-01-30

ApplicantShanghai PT Plastics Enterprise Company, Ltd.
Decision Date1997-01-30
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PATIENT EXAMINATION GLOVE 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 1997-01-30 under 510(k) number K961521. 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 PATIENT EXAMINATION GLOVE?

PATIENT EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1997-01-30. The listed applicant is Shanghai PT Plastics Enterprise Company, Ltd.. The 510(k) number is K961521.

When did PATIENT EXAMINATION GLOVE receive FDA 510(k) clearance?

PATIENT EXAMINATION GLOVE received FDA 510(k) clearance on 1997-01-30, under 510(k) number K961521.

Who is the listed applicant for PATIENT EXAMINATION GLOVE?

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 PATIENT EXAMINATION GLOVE?

The FDA product code for PATIENT EXAMINATION GLOVE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 COLORK001611DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREEK001601DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVESK963751PT 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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