Company ยท MY
Terang Nusa Sdn Bhd
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2017. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 24, 2017 | K170779 | Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable pr Terang Nusa Sdn Bhd, MY | LYY |
| Nov 28, 2016 | K161932 | Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink Terang Nusa Sdn Bhd, MY | LZA |
| Mar 21, 2016 | K153510 | Powder Free Polychloroprene Examination Glove Green Terang Nusa Sdn Bhd, MY | LZA |
| Sep 18, 2015 | K151392 | Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less Terang Nusa Sdn Bhd, MY | KGO |
| Nov 6, 2014 | K140355 | SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM Terang Nusa Sdn Bhd, MY | KGO |
| Dec 7, 2011 | K110698 | NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE Terang Nusa Sdn Bhd, MY | KGO |
| Sep 10, 2010 | K102230 | NUGARD NITILE GREY COLOR Terang Nusa Sdn Bhd, MY | LZA |
| Aug 27, 2010 | K102119 | SUR-G GLOV AND MAXITEX Terang Nusa Sdn Bhd, MY | KGO |
| Jan 27, 2009 | K083337 | NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES Terang Nusa Sdn Bhd, MY | LYY |
| Nov 21, 2005 | K052837 | SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA Terang Nusa Sdn Bhd, MY | KGO |
| Oct 20, 2005 | K051562 | NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR Terang Nusa Sdn Bhd, MY | KGO |
| Jun 20, 2005 | K051563 | NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED Terang Nusa Sdn Bhd, MY | KGO |
| Jun 6, 2005 | K051094 | NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE Terang Nusa Sdn Bhd, MY | KGO |
| Sep 16, 2004 | K041437 | MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE Terang Nusa Sdn Bhd, MY | KGO |
| Aug 20, 2004 | K041436 | SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2 Terang Nusa Sdn Bhd, MY | KGO |
| May 1, 2001 | K010439 | MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) Terang Nusa Sdn Bhd, MY | KGO |
| May 1, 2001 | K010438 | MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS) Terang Nusa Sdn Bhd, MY | KGO |
| Dec 21, 2000 | K003547 | NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) Terang Nusa Sdn Bhd, MY | LYY |
| Dec 21, 2000 | K003545 | NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE Terang Nusa Sdn Bhd, MY | LYY |
| May 23, 2000 | K000178 | NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN Terang Nusa Sdn Bhd, MY | KGO |
| May 15, 2000 | K000179 | NUZONE NITRILE SURGICAL GLOVES POWDER FREE Terang Nusa Sdn Bhd, MY | KGO |
| May 28, 1999 | K990488 | SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE Terang Nusa Sdn Bhd, MY | LYY |
| May 17, 1999 | K990841 | NUGARD NITRIL NITRILE EXAMINATION GLOVE Terang Nusa Sdn Bhd, MY | LZA |
| May 17, 1999 | K990840 | NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE Terang Nusa Sdn Bhd, MY | LZA |
| Jan 13, 1999 | K982957 | SENSIFLEX POWDERFREE SURGEON'S GLOVE Terang Nusa Sdn Bhd, MY | KGO |
| Mar 22, 1989 | K891245 | PATIENT EXAMINATION GLOVES (LATEX) Terang Nusa Sdn Bhd, MY | LYY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2007 | Terang Nusa Sdn Bhd Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1 pair of gloves per package, 100 packages per case; Manufactured for Medline Industries, Inc Terminated |
KGO | K051563 |
| Jun 27, 2006 | Terang Nusa Sdn Bhd Sterile Triumph LT Latex Powder-Free Surgeons Gloves; 50 pairs of gloves per box, 4 boxes per carton; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malayia Terminated |
KGO | K982957 |