MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)— 510(k) K003055
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K003055 for MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS), Substantially Equivalent on 2001-01-26. Applicant: Medline Industries, Inc.. Device class: 1.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code LYY
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mundelein, IL, US
Recent devices under product code LYY
view all- K250069 — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
- K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White)
- K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
- K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
- K222612 — Powder-Free Latex examination gloves
More clearances from Medline Industries, Inc.
view all- DEN210049 — Medline ART Skin Harvesting System
- K230559 — Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
- K223100 — Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
- K222665 — Medline UNITE® Ankle Fusion Plating System
- K213054 — Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
Data sourced from openFDA. This site is unofficial and independent of the FDA.