Terang Nusa (Malaysia) Sdn. Bhd.
Kota Bharu Kelantan, MY
TERANG NUSA (MALAYSIA) SDN. BHD. appears in FDA device records in Kota Bharu Kelantan, MY. FDA records list 26 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Terang Nusa (Malaysia) Sdn. Bhd. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Terang Nusa Sdn Bhd510(k), recall
510(k) clearance history
FDA records hold 26 510(k) clearances for Terang Nusa (Malaysia) Sdn. Bhd. between 1989 and 2017. The busiest year on record is 1999, with 4. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1999 | 4 |
| 2000 | 4 |
| 2001 | 2 |
| 2004 | 2 |
| 2005 | 4 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K170779 | Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein | LYY | Substantially Equivalent | |
| K161932 | Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink | LZA | Substantially Equivalent | |
| K153510 | Powder Free Polychloroprene Examination Glove Green | LZA | Substantially Equivalent | |
| K151392 | Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less | KGO | Substantially Equivalent | |
| K140355 | SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM | KGO | Substantially Equivalent | |
| K110698 | NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE | KGO | Substantially Equivalent | |
| K102230 | NUGARD NITILE GREY COLOR | LZA | Substantially Equivalent | |
| K102119 | SUR-G GLOV AND MAXITEX | KGO | Substantially Equivalent | |
| K083337 | NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K052837 | SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA | KGO | Substantially Equivalent | |
| K051562 | NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR | KGO | Substantially Equivalent | |
| K051563 | NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED | KGO | Substantially Equivalent | |
| K051094 | NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE | KGO | Substantially Equivalent | |
| K041437 | MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE | KGO | Substantially Equivalent | |
| K041436 | SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2 | KGO | Substantially Equivalent | |
| K010439 | MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | |
| K010438 | MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS) | KGO | Substantially Equivalent | |
| K003547 | NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K003545 | NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE | LYY | Substantially Equivalent | |
| K000178 | NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN | KGO | Substantially Equivalent | |
| K000179 | NUZONE NITRILE SURGICAL GLOVES POWDER FREE | KGO | Substantially Equivalent | |
| K990488 | SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K990841 | NUGARD NITRIL NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K990840 | NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K982957 | SENSIFLEX POWDERFREE SURGEON'S GLOVE | KGO | Substantially Equivalent | |
| K891245 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012304897 | 3012304897 | TERANG NUSA (MALAYSIA) SDN. BHD. | 2, Jalan 8, Pengkalan Chepa Industrial Zone 2, Kota Bharu Kelantan 16100 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0365-2007 | 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., Mundelein, IL 60060 U.S.A., Made in Malaysia | Some of the packages labeled as latex-free actually contain latex gloves. | Terminated | ||
| Z-1185-06 | 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 | The sterile glove pouches may have an open seal at the bottom of the pouch. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain