Last synced on 25 January 2026 at 3:41 am

Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220371
510(k) Type
Traditional
Applicant
Summit Glove, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/2/2022
Days to Decision
266 days
Submission Type
Statement

Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220371
510(k) Type
Traditional
Applicant
Summit Glove, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/2/2022
Days to Decision
266 days
Submission Type
Statement