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FDA 510(k)

POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O

K-Number: K092492 · 2009-10-21

ApplicantWear Safe (Malaysia) Sdn. Bhd.
Decision Date2009-10-21
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O is the device name listed in this FDA 510(k) record. The listed applicant is Wear Safe (Malaysia) Sdn. Bhd.. It received FDA 510(k) clearance on 2009-10-21 under 510(k) number K092492. 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 POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O?

POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O is a medical device that received FDA 510(k) clearance on 2009-10-21. The listed applicant is Wear Safe (Malaysia) Sdn. Bhd.. The 510(k) number is K092492.

When did POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O receive FDA 510(k) clearance?

POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O received FDA 510(k) clearance on 2009-10-21, under 510(k) number K092492.

Who is the listed applicant for POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O?

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

What is the FDA product code for POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O?

The FDA product code for POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O is LYY.

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Other records listing Wear Safe (Malaysia) Sdn. Bhd. 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.

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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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