510(k) · Cleared
ClearedSafecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bam Corporation Limited · QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Cleared on Jul 7, 2017 as substantially equivalent to K925077 (Medtek Development Corp., 1993) after a 515-day review. Its family tree reaches back 1 generation to 1993. 5 later devices descend from it.
- Decided
- Jul 7, 2017
- Review
- 515 days
- Class
- Class II
- Product code
- QPC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925077 (1993). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK925077 Poly-Med Disp. Pers. Prot. Gown Apron & ShoecoversMedtek Development Corp. · 1993
- This deviceK160337 Safecare Open Back Protective Gowns and ValueCare Open Back…Bam Corporation Limited · 2017
- Descendant · cites it directly · 2 of its ownK210405 ProTEC-USA EZDoff GownCadillac Products, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK233526 Medline Open-back Level 3 Protective GownMedline Industries, LP · 2024
- Descendant · 3 generations on · 0 of its ownK262007 PRIMED AAMI Level 3 Open Back GownsPRIMED Medical Products, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK203821 Donagamex Blue Performance Protective GownDong Nai Garment Corporation (Donagamex) · 2021
- Descendant · cites it directly · 0 of its ownK211538 Protect X Level 3 Isolation GownAzac Group · 2021
Most influential descendants
Showing 5 of 5 · See all- K210405ProTEC-USA EZDoff GownCadillac Products, Inc. · 2021 · cites it directly2descendants
- K233526Medline Open-back Level 3 Protective GownMedline Industries, LP · 2024 · 2 generations on1descendant
- K262007PRIMED AAMI Level 3 Open Back GownsPRIMED Medical Products, Inc. · 2026 · 3 generations on0descendants
- K203821Donagamex Blue Performance Protective GownDong Nai Garment Corporation (Donagamex) · 2021 · cites it directly0descendants
- K211538Protect X Level 3 Isolation GownAzac Group · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925077 | Poly-Med Disp. Pers. Prot. Gown Apron & Shoecovers | Medtek Development Corp. | 1993 | — |
| 0 (this device) | K160337 | Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns | Bam Corporation Limited | 2017 | — |
| +1 | K210405 | ProTEC-USA EZDoff Gown | Cadillac Products, Inc. | 2021 | — |
| +2 | K233526 | Medline Open-back Level 3 Protective Gown | Medline Industries, LP | 2024 | — |
| +3 | K262007 | PRIMED AAMI Level 3 Open Back Gowns | PRIMED Medical Products, Inc. | 2026 | — |
| +1 | K203821 | Donagamex Blue Performance Protective Gown | Dong Nai Garment Corporation (Donagamex) | 2021 | — |
| +1 | K211538 | Protect X Level 3 Isolation Gown | Azac Group | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QPC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QPC device
- #1 K262007 PRIMED AAMI Level 3 Open Back Gownsscore 12.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K925077 | Poly-Med Disp. Pers. Prot. Gown Apron & ShoecoversSummary page 6…ut taking over the head in case they are contaminated Predicate Device: Poly-Med Disposable Personal Protective Gown Apron, 510(k) K925077 510(k) Summary Page 1 out of 4 Indications for… | 1993 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K210405 (Cadillac Products, Inc., 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QPC devicesQPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · QPC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QPC
Too few QPC 510(k)s in any year since 2007 to give a median.
Recalls per year · QPC
No recall names QPC since 2007.
Adverse event reports per year · QPC
No MAUDE report names QPC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
These gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The back of the gown is open and non-protective. They are not intended for use in the operating room.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160337: Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160337
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026