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FDA 510(k)

SYNTEX

K-Number: K971360 · 1997-12-22

ApplicantShinemound Enterprise, Inc.
Decision Date1997-12-22
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYNTEX is the device name listed in this FDA 510(k) record. The listed applicant is Shinemound Enterprise, Inc.. It received FDA 510(k) clearance on 1997-12-22 under 510(k) number K971360. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTEX?

SYNTEX is a medical device that received FDA 510(k) clearance on 1997-12-22. The listed applicant is Shinemound Enterprise, Inc.. The 510(k) number is K971360.

When did SYNTEX receive FDA 510(k) clearance?

SYNTEX received FDA 510(k) clearance on 1997-12-22, under 510(k) number K971360.

Who is the listed applicant for SYNTEX?

The FDA 510(k) record lists Shinemound Enterprise, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTEX?

The FDA product code for SYNTEX is LYZ.

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Other records listing Shinemound Enterprise, Inc. 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.

K051913POWDERED LATEX PATIENT EXAMINATION GLOVESK994248SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVESK994258SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVESK993240SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVESK993231SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVESK972104LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES

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Related Devices (Code: LYZ)

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.

K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation

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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