Last synced on 27 June 2025 at 11:06 pm

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
FDA Hosted 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
FDA Hosted 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