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FDA 510(k)

SURE-TEC LATEX EXAMINATION GLOVES

K-Number: K894739 · 1989-09-26

ApplicantAll American Poly of Pennsylvania Corp.
Decision Date1989-09-26
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURE-TEC LATEX EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is All American Poly of Pennsylvania Corp.. It received FDA 510(k) clearance on 1989-09-26 under 510(k) number K894739. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURE-TEC LATEX EXAMINATION GLOVES?

SURE-TEC LATEX EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1989-09-26. The listed applicant is All American Poly of Pennsylvania Corp.. The 510(k) number is K894739.

When did SURE-TEC LATEX EXAMINATION GLOVES receive FDA 510(k) clearance?

SURE-TEC LATEX EXAMINATION GLOVES received FDA 510(k) clearance on 1989-09-26, under 510(k) number K894739.

Who is the listed applicant for SURE-TEC LATEX EXAMINATION GLOVES?

The FDA 510(k) record lists All American Poly of Pennsylvania Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURE-TEC LATEX EXAMINATION GLOVES?

The FDA product code for SURE-TEC LATEX EXAMINATION GLOVES is LYY.

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Related Devices (Code: LYY)

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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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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