Search Results
Found 2 results
510(k) Data Aggregation
K Number
K222527Device Name
Nitrile Patient Examination Glove
Manufacturer
Date Cleared
2022-12-14
(114 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PingAn Medical Products Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
Ask a Question
Ask a specific question about this device
K Number
K210725Device Name
Nitrile Patient Examination Glove
Manufacturer
Date Cleared
2021-08-06
(149 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PingAn Medical Products Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nitrile Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
Ask a Question
Ask a specific question about this device
Page 1 of 1