Yty Industry (Manjung) Sdn. Bhd.
SITIAWAN Perak, MY
YTY INDUSTRY (MANJUNG) SDN. BHD. appears in FDA device records in SITIAWAN Perak, MY. FDA records list 27 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 27 510(k) clearances for Yty Industry (Manjung) Sdn. Bhd. between 1989 and 2023. The busiest year on record is 2003, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 2 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 3 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2011 | 2 |
| 2014 | 1 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220644 | Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs | LZA | Substantially Equivalent | |
| K202536 | Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | |
| K200453 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC | LZA | Substantially Equivalent | |
| K182383 | Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue | LZC | Substantially Equivalent | |
| K171104 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue) | LZA | Substantially Equivalent | |
| K162095 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) | LZA | Substantially Equivalent | |
| K143289 | NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR | LZA | Substantially Equivalent | |
| K143055 | Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla | LZA | Substantially Equivalent | |
| K142283 | Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color) | LZA | Substantially Equivalent | |
| K133123 | NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F | LZA | Substantially Equivalent | |
| K111248 | NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE) | LZA | Substantially Equivalent | |
| K101820 | NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K061553 | NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K052502 | NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K033887 | NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K031384 | MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G | LZA | Substantially Equivalent | |
| K030164 | NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK COLOR, LATEX EXAMINATION GLOVES WITH PROTEIN | LYY | Substantially Equivalent | |
| K024355 | EVERGREEN NON-STERILE POWDERED NATURAL OR COLORED LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K023577 | POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH PROTEIN LABELING (<50UN/G) | LYY | Substantially Equivalent | |
| K023590 | POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES | LYY | Substantially Equivalent | |
| K011376 | EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN LABELING (200 | LYY | Substantially Equivalent | |
| K991742 | NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM O | LYY | Substantially Equivalent | |
| K990013 | EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K983608 | EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM EXAMINATION GLOVES: NATURAL, BLUE & PINK | LYY | Substantially Equivalent | |
| K974191 | EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K974518 | NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED | LYY | Substantially Equivalent | |
| K892611 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9613997 | 3002563423 | YTY INDUSTRY (MANJUNG) SDN. BHD. | LOT 1422-1424, BATU 10 LEKIR, SITIAWAN Perak 32020 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain