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FDA 510(k)

POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES

K-Number: K010628 · 2001-04-23

Decision Date2001-04-23
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Shijiazhuang Junfei Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2001-04-23 under 510(k) number K010628. 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 POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES?

POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2001-04-23. The listed applicant is Shijiazhuang Junfei Plastic Products Co., Ltd.. The 510(k) number is K010628.

When did POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES receive FDA 510(k) clearance?

POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES received FDA 510(k) clearance on 2001-04-23, under 510(k) number K010628.

Who is the listed applicant for POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES?

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

What is the FDA product code for POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES?

The FDA product code for POWDERED SYNTHETIC VINYL PATIENT 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.

Other records listing Shijiazhuang Junfei Plastic 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.

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.

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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