FDA 510(k)

DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM

K-Number: K955425 · 1996-12-30

Decision Date1996-12-30

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM is the device name listed in this FDA 510(k) record. The listed applicant is Dash Medical Gloves Sdn Bhd. It received FDA 510(k) clearance on 1996-12-30 under 510(k) number K955425. 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 DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM?

DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM is a medical device that received FDA 510(k) clearance on 1996-12-30. The listed applicant is Dash Medical Gloves Sdn Bhd. The 510(k) number is K955425.

When did DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM receive FDA 510(k) clearance?

DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM received FDA 510(k) clearance on 1996-12-30, under 510(k) number K955425.

Who is the listed applicant for DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM?

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

What is the FDA product code for DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM?

The FDA product code for DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM is LYY.

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.

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Other records listing Dash Medical Gloves Sdn Bhd as applicant

K992128DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS K974114DASH, VITAL GARD

Related Devices (Code: LYY)

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn Bhd K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

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.