510(k) · Cleared
ClearedBiogel Orthopro Indicator Underglove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Molnlycke Health Care USA · KGO Surgeon'S Gloves
Cleared on Nov 23, 2010 as substantially equivalent to K071565 (Molnlycke Health Care Us, LLC, 2007) and 2 other predicates after a 211-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Nov 23, 2010
- Review
- 211 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K033564 (2004). 6 ancestors in all, the oldest K980516 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK033564 Powder Free Latex Surgeons Gloves Polymer Coated Sterile with…Kanam Latex Industries Pvt., Ltd. · 2004
- 2 generations backK060030 The Double GloveBiobarrier, Inc. · 2006
- 1 generation backK071565 Biogel Indicator Underglove with Non-Pyrogenic StatementMolnlycke Health Care Us, LLC · 2007
- This deviceK101163 Biogel Orthopro Indicator UndergloveMolnlycke Health Care USA · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K033564 | Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional… | Kanam Latex Industries Pvt., Ltd. | 2004 | — |
| −2 | K060030 | The Double Glove | Biobarrier, Inc. | 2006 | — |
| −1 | K071565 | Biogel Indicator Underglove with Non-Pyrogenic Statement | Molnlycke Health Care Us, LLC | 2007 | — |
| 0 (this device) | K101163 | Biogel Orthopro Indicator Underglove | Molnlycke Health Care USA | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2007 | 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 KGO? 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 KGO device
- #1 K192328 JR.MEDIK Latex Surgeon’s Gloves Powder Freescore 15.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K071565 | Biogel Indicator Underglove with Non-Pyrogenic StatementSummary page 1…21 CFR 878.4460 Product Code: KGO Predicate Device Name(s): Bliogelt- Indicator' Underglove (K071565 and K980942) Biogcl" Orthopedic Surgical Glove (K07 1465)… | 2007 |
| * | K980942 | Regent Biogel Indicator Inner Surgical GloveSummary page 1…R 878.4460 Product Code: KGO Predicate Device Name(s): Bliogelt- Indicator' Underglove (K071565 and K980942) Biogcl" Orthopedic Surgical Glove (K07 1465)… | 1998 |
| * | K071465 | Biogel Orthopaedic Surgical Glove with Non-Pryogenic StatementSummary page 1…Bliogelt- Indicator' Underglove (K071565 and K980942) Biogcl" Orthopedic Surgical Glove (K07 1465) Page 40 of 204 ?flYCL… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KGO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGO
185in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGO
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGO
21in 2025
MAUDE reports naming product code KGO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 113 | 0 | 13 |
| 2008 | 2 | — | 0 | 8 |
| 2009 | 3 | 48 | 15 | 14 |
| 2010 | 6 | 87 | 1 | 16 |
| 2011 | 11 | 90 | 0 | 14 |
| 2012 | 7 | 133 | 0 | 14 |
| 2013 | 6 | 184 | 0 | 41 |
| 2014 | 7 | 257 | 0 | 28 |
| 2015 | 12 | 225 | 0 | 11 |
| 2016 | 9 | 218 | 2 | 15 |
| 2017 | 12 | 111 | 1 | 20 |
| 2018 | 7 | 194 | 8 | 15 |
| 2019 | 11 | 204 | 0 | 51 |
| 2020 | 15 | 117 | 0 | 15 |
| 2021 | 14 | 199 | 0 | 14 |
| 2022 | 6 | 127 | 2 | 10 |
| 2023 | 14 | 185 | 2 | 28 |
| 2024 | 2 | — | 0 | 18 |
| 2025 | 1 | — | 0 | 21 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Biogel® OrthoPro® Indicator® Underglove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101163 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101163: Biogel Orthopro Indicator Underglove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101163
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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