Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.” (first 1989, latest 1995), across 1 product code in 1 review panel. Median 510(k) review time under this name: 70 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 | 5 | 5 |
Review panels
- General Hospital (5)
Most recent Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952588 | ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES | LYY | 1995-10-12 | 129 |
| K952590 | ROYAL SHIELD NON-STERILE PINK COLOERED, STRAWBERRY SCENTED LATEX EXAMINATION GLOVES | LYY | 1995-08-14 | 70 |
| K952591 | ROYAL SHIELD NON-STERILE BLUE COLORED BUBBLE GUM SCENTED LATEX EXAMINATION GLOVES | LYY | 1995-08-11 | 67 |
| K926132 | ROYAL SHIELD SHIELD GLOVES | LYY | 1993-12-22 | 380 |
| K890907 | ROYAL SHIELD LATEX EXAMINATION GLOVES(TM) | LYY | 1989-04-26 | 61 |
Recalls
openFDA lists no recalls under a recalling firm named Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Shield Diagnostics, Ltd. (27 510(k)s)
- Shield Gloves Manufacturer (M) Sdn Bhd (18 510(k)s)
- Shield Laboratories, Inc. (2 510(k)s)
- Shield Computers , Ltd. (1 510(k)s)
- Shield Gloves Medical Products Sdn Bhd (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.” (first 1989, latest 1995), across 1 product code 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 Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. is 70 days.
Which FDA product codes appear under Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 5).
Next steps
- See all 5 Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.'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.