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FDA 510(k)

SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

K-Number: K004048 · 2001-02-06

ApplicantTillotson Healthcare Corp.
Decision Date2001-02-06
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) is the device name listed in this FDA 510(k) record. The listed applicant is Tillotson Healthcare Corp.. It received FDA 510(k) clearance on 2001-02-06 under 510(k) number K004048. 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 SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)?

SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) is a medical device that received FDA 510(k) clearance on 2001-02-06. The listed applicant is Tillotson Healthcare Corp.. The 510(k) number is K004048.

When did SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) receive FDA 510(k) clearance?

SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) received FDA 510(k) clearance on 2001-02-06, under 510(k) number K004048.

Who is the listed applicant for SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)?

The FDA 510(k) record lists Tillotson Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)?

The FDA product code for SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS 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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