Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein— 510(k) K202449
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K202449 for Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein, Substantially Equivalent on 2020-11-18. Applicant: Medline Industries, Inc.. Device class: 1.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northfiled, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.