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FDA 510(k)

POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)

K-Number: K001327 · 2000-05-23

ApplicantPremier Pathway Sdn. Bhd.
Decision Date2000-05-23
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS) is the device name listed in this FDA 510(k) record. The listed applicant is Premier Pathway Sdn. Bhd.. It received FDA 510(k) clearance on 2000-05-23 under 510(k) number K001327. 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 POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)?

POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS) is a medical device that received FDA 510(k) clearance on 2000-05-23. The listed applicant is Premier Pathway Sdn. Bhd.. The 510(k) number is K001327.

When did POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS) receive FDA 510(k) clearance?

POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS) received FDA 510(k) clearance on 2000-05-23, under 510(k) number K001327.

Who is the listed applicant for POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)?

The FDA 510(k) record lists Premier Pathway Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)?

The FDA product code for POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS) 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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