SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove

Polymer Patient Examination Glove

Showa Best Glove, Inc.

The following data is part of a premarket notification filed by Showa Best Glove, Inc. with the FDA for Showa(r) Blue Nitrile Powder Free Medical Examination Glove.

Pre-market Notification Details

• Device ID: K211003
• 510k Number: K211003
• Device Name: SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove
• Classification: Polymer Patient Examination Glove
• Applicant: Showa Best Glove, Inc. 579 Edison Street Menlo, GA 30731
• Contact: Jeffrey Richardson
• Correspondent: Jeffrey Richardson; Showa Best Glove, Inc. 579 Edison Street Menlo, GA 30731
• Product Code: LZA
• CFR Regulation Number: 880.6250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-04-02
• Decision Date: 2022-01-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20038054686493	K211003	000
10038054654310	K211003	000
00038054654368	K211003	000
10038054654372	K211003	000
10038054654389	K211003	000
10038054654396	K211003	000
20038054686400	K211003	000
20038054686417	K211003	000
20038054686462	K211003	000
20038054686479	K211003	000
20038054686486	K211003	000
10038054654303	K211003	000