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FDA 510(k)

VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB

K-Number: K000488 · 2000-03-20

ApplicantSgmp Co., Ltd.
Decision Date2000-03-20
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB is the device name listed in this FDA 510(k) record. The listed applicant is Sgmp Co., Ltd.. It received FDA 510(k) clearance on 2000-03-20 under 510(k) number K000488. 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 VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB?

VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB is a medical device that received FDA 510(k) clearance on 2000-03-20. The listed applicant is Sgmp Co., Ltd.. The 510(k) number is K000488.

When did VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB receive FDA 510(k) clearance?

VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB received FDA 510(k) clearance on 2000-03-20, under 510(k) number K000488.

Who is the listed applicant for VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB?

The FDA 510(k) record lists Sgmp Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB?

The FDA product code for VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB is LYY.

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Other records listing Sgmp Co., Ltd. as applicant

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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