Spi Gloves Sdn. Bhd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Spi Gloves Sdn. Bhd.” (first 2005, latest 2005), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 16 days. 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 | 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 | 4 | 4 |
| LZA | Polymer Patient Examination Glove | 3 | 3 |
Review panels
- General Hospital (7)
Most recent Spi Gloves Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050526 | POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR | LYY | 2005-12-06 | 279 |
| K050528 | POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK) | LZA | 2005-05-19 | 78 |
| K050532 | CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA | LYY | 2005-04-14 | 43 |
| K050531 | POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE) | LZA | 2005-03-18 | 16 |
| K050527 | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL | LYY | 2005-03-18 | 16 |
| K050530 | POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN) | LZA | 2005-03-16 | 14 |
| K050529 | POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER | LYY | 2005-03-16 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Spi Gloves 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Spi Gloves Sdn. Bhd.?
FDA lists 7 510(k) clearances under the applicant name “Spi Gloves Sdn. Bhd.” (first 2005, latest 2005), across 2 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 Spi Gloves Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spi Gloves Sdn. Bhd. is 16 days.
Which FDA product codes appear under Spi Gloves Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 4); LZA (Polymer Patient Examination Glove, 3).
Next steps
- See all 7 Spi Gloves Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Spi Gloves 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.