Shield Gloves Manufacturer (M) Sdn Bhd: FDA clearances and approvals
Shield Gloves Manufacturer (M) Sdn Bhd has 18 FDA 510(k) clearances (first 1994, latest 2001), across 2 product codes in 1 review panel. Median 510(k) review time: 55 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 15 | 15 |
| LZA | Polymer Patient Examination Glove | 3 | 3 |
Review panels
- General Hospital (18)
Most recent Shield Gloves Manufacturer (M) Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011613 | POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE | LZA | 2001-09-17 | 115 |
| K000217 | ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W | LYY | 2000-02-18 | 25 |
| K000156 | SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES | LYY | 2000-02-18 | 30 |
| K992419 | ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR | LYY | 1999-09-13 | 55 |
| K992418 | ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI | LYY | 1999-09-13 | 55 |
| K992417 | ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR | LYY | 1999-09-13 | 55 |
| K991746 | ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR | LYY | 1999-06-23 | 33 |
| K991745 | ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM | LYY | 1999-06-23 | 33 |
| K991744 | SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT | LZA | 1999-06-23 | 33 |
| K991743 | ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O | LYY | 1999-06-23 | 33 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shield Gloves Manufacturer (M) Sdn Bhd.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Shield Gloves Manufacturer (M) Sdn Bhd have?
Shield Gloves Manufacturer (M) Sdn Bhd has 18 FDA 510(k) clearances (first 1994, latest 2001), across 2 product codes in 1 review panel.
How long does FDA take to clear Shield Gloves Manufacturer (M) Sdn Bhd's 510(k)s?
The median time from FDA receipt to decision across Shield Gloves Manufacturer (M) Sdn Bhd's cleared 510(k)s is 55 days.
What devices does Shield Gloves Manufacturer (M) Sdn Bhd make?
Its most frequent FDA product codes are LYY (Latex Patient Examination Glove, 15); LZA (Polymer Patient Examination Glove, 3).
Has Shield Gloves Manufacturer (M) Sdn Bhd had device recalls?
openFDA lists no recalls under a recalling firm name matching Shield Gloves Manufacturer (M) Sdn Bhd. Related entities may recall under other names.
Next steps
- See all 18 Shield Gloves Manufacturer (M) Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LYY, Shield Gloves Manufacturer (M) Sdn Bhd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.