Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)— 510(k) K223298
Substantially EquivalentShandong Intco Medical Products Co, Ltd.
FDA 510(k) clearance K223298 for Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L), Substantially Equivalent on 2023-02-22. Applicant: Shandong Intco Medical Products Co, Ltd.. Device class: 1.
Clearance details
- Applicant
- Shandong Intco Medical Products Co, Ltd.
- 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
- Qingzhou, CN
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)
- K222612 — Powder-Free Latex examination gloves
- K221667 — Non Sterile Powder Free Latex Examination Glove
More clearances from Shandong Intco Medical Products Co, Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.