Yty Industry (Manjung) Sdn Bhd: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Yty Industry (Manjung) Sdn Bhd” (first 1989, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 78 days. Since 2017 the median was 200 days, against 112 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 242 |
| 2015 | 3 | 154 |
| 2016 | 1 | 97 |
| 2017 | 1 | 134 |
| 2018 | 0 | — |
| 2019 | 1 | 200 |
| 2020 | 1 | 67 |
| 2021 | 1 | 344 |
| 2022 | 0 | — |
| 2023 | 1 | 386 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Yty Industry (Manjung) Sdn Bhd took a median 200 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 16 | 16 |
| LYY | Latex Patient Examination Glove | 10 | 10 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (27)
Most recent Yty Industry (Manjung) Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220644 | Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs | LZA | 2023-03-25 | 386 |
| 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 | 2021-08-11 | 344 |
| K200453 | NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC | LZA | 2020-05-01 | 67 |
| K182383 | Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue | LZC | 2019-03-19 | 200 |
| K171104 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue) | LZA | 2017-08-25 | 134 |
| K162095 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) | LZA | 2016-11-02 | 97 |
| K143289 | NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR | LZA | 2015-08-18 | 274 |
| K143055 | Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla | LZA | 2015-02-12 | 112 |
| K142283 | Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color) | LZA | 2015-01-16 | 154 |
| K133123 | NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F | LZA | 2014-05-30 | 242 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Yty Industry (Manjung) Sdn Bhd.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Yty Industry (Manjung) Sdn Bhd is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04274647: Skin Sensitization Test (Modified Draize-95 Test) (Completed, started 2019-09-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under Yty Industry (Manjung) Sdn Bhd?
FDA lists 27 510(k) clearances under the applicant name “Yty Industry (Manjung) Sdn Bhd” (first 1989, latest 2023), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Yty Industry (Manjung) Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Yty Industry (Manjung) Sdn Bhd is 78 days. Since 2017: 200 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Yty Industry (Manjung) Sdn Bhd?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 16); LYY (Latex Patient Examination Glove, 10); LZC (Medical Glove, Specialty, 1).
Next steps
- See all 27 Yty Industry (Manjung) Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LZA, Yty Industry (Manjung) Sdn Bhd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.