LATEX EXAMINATION GLOVE POWDER FREE— 510(k) K152593
Substantially EquivalentCareplus (M) Sdn Bhd
FDA 510(k) clearance K152593 for LATEX EXAMINATION GLOVE POWDER FREE, Substantially Equivalent on 2016-02-25. Applicant: Careplus (M) Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Careplus (M) Sdn Bhd
- 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
- Seremban, MY
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 Careplus (M) Sdn Bhd
view all- K211621 — Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)
- K201857 — Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
- K203705 — Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)
- K210724 — ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
- K210656 — ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
Data sourced from openFDA. This site is unofficial and independent of the FDA.