FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM
K Number: K140355
·
Decision Nov 6, 2014
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
558
Applicant Total
26
Review Days
267
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Basic Information
- Device Name
- SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM
- K Number
- K140355
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4460
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Terang Nusa Sdn Bhd
- Date Received
- February 12, 2014
- Decision Date
- November 6, 2014
- Product Code
- KGO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KGO | Surgeon'S Gloves | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Terang Nusa Sdn Bhd
| K Number | Device Name | ||
|---|---|---|---|
| K170779 | Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein | May 24, 2017 | Substantially Equivalent |
| K161932 | Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink | Nov 28, 2016 | Substantially Equivalent |
| K153510 | Powder Free Polychloroprene Examination Glove Green | Mar 21, 2016 | Substantially Equivalent |
| K151392 | Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less | Sep 18, 2015 | Substantially Equivalent |
| K110698 | NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE | Dec 7, 2011 | Substantially Equivalent |
| K102230 | NUGARD NITILE GREY COLOR | Sep 10, 2010 | Substantially Equivalent |
| K102119 | SUR-G GLOV AND MAXITEX | Aug 27, 2010 | Substantially Equivalent |
| K083337 | NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES | Jan 27, 2009 | Substantially Equivalent |
| K052837 | SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA | Nov 21, 2005 | Substantially Equivalent |
| K051562 | NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR | Oct 20, 2005 | Substantially Equivalent |