510(k) Report

510(k) · Cleared

Cleared

Global Healthcare Self-Sealing Sterilization Pouch

K990567510(k) TraditionalCleared Apr 5, 199941-day reviewClass II21 CFR 880.6850

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Global Healthcare, Inc. · FRG Wrap, Sterilization

Cleared on Apr 5, 1999 after a 41-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 31 later devices descend from it.

Decided
Apr 5, 1999
Review
41 days
Class
Class II
Product code
FRG
Recalls
None
Predicates
0

31 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2005: 1 descendant cleared1999: 1 descendant cleared2011: 2 descendants cleared2012: 1 descendant cleared2018: 2 descendants cleared2021: 2 descendants cleared2017: 2 descendants cleared2015: 2 descendants cleared2016: 2 descendants cleared2019: 4 descendants cleared2025: 6 descendants cleared2022: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK990567 Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc. · 1999
  2. Descendant · cites it directly · 30 of its ownK993764 Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co. · 1999
  3. Descendant · cites it directly · 29 of its ownK051242 Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc. · 2005
  4. Descendant · 2 generations on · 19 of its ownK070428 Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc. · 2007
  5. Descendant · 2 generations on · 16 of its ownK102158 Sigma Sterilization Pouch & RollSigma Medical Supplies Corp. · 2011
  6. Descendant · cites it directly · 7 of its ownK062704 Sterilization Pouch with IndicatorsWinner Industries (Shenzhen) Co., Ltd. · 2007

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

1999: 12005: 12007: 22011: 22012: 12015: 22016: 22017: 22018: 22019: 42021: 22022: 12023: 12024: 12025: 62026: 1
1999high 6 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 31 · See all
  • K993764Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co. · 1999 · cites it directly30descendants
  • K051242Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc. · 2005 · cites it directly29descendants
  • K070428Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc. · 2007 · 2 generations on19descendants
  • K102158Sigma Sterilization Pouch & RollSigma Medical Supplies Corp. · 2011 · 2 generations on16descendants
  • K062704Sterilization Pouch with IndicatorsWinner Industries (Shenzhen) Co., Ltd. · 2007 · cites it directly7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K990567Global Healthcare Self-Sealing Sterilization PouchGlobal Healthcare, Inc.1999—
+1K993764Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co.1999—
+1K051242Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc.2005—
+2K070428Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc.2007—
+2K102158Sigma Sterilization Pouch & RollSigma Medical Supplies Corp.2011—
+1K062704Sterilization Pouch with IndicatorsWinner Industries (Shenzhen) Co., Ltd.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200510
200720
201120
201210
201520
201620
201720
201820
201940
202120
202210
202310
202410
202560
202610
FIG. 1 — Lineage of K990567, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FRG? 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 FRG device

  1. #1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (31)

See all 31

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993764Medipack See-Through Seal Sterilization PouchMedipack Medical Packaging Mfg. Co.199930
K051242Winner Self Seal Sterilization PouchWinner Medical (Usa), Inc.200529
K062704Sterilization Pouch with IndicatorsWinner Industries (Shenzhen) Co., Ltd.20077

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?

  • Of its descendants, K993764 (Medipack Medical Packaging Mfg. Co., 1999) has gone furthest, with 30 descendants of its own.

How does its category compare?

All FRG devices

FRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRG

9in 2025

2007: 32008: 22009: 42010: 42011: 62012: 102013: 62014: 82015: 122016: 92017: 92018: 52019: 92020: 52021: 42022: 92023: 92024: 112025: 92026 (partial year): 4
2007high 12 (2015) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRG

151in 2025

2007: 182 days median2009: 171 days median2010: 213 days median2011: 110 days median2012: 133 days median2013: 146 days median2014: 177 days median2015: 196 days median2016: 131 days median2017: 260 days median2018: 150 days median2019: 258 days median2020: 122 days median2021: 170 days median2022: 217 days median2023: 230 days median2024: 182 days median2025: 151 days median2026 (partial year): 247 days median
2007high 260 (2017) · low 110 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRG

2in 2022

2013: 22017: 292020: 142022: 2
2007high 29 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FRG

18in 2025

2007: 12008: 22009: 22011: 122012: 42013: 52014: 132015: 92016: 202017: 72018: 222019: 102020: 212021: 92022: 42023: 132024: 212025: 18
2007high 22 (2018) · low 0 (2010)2025

MAUDE reports naming product code FRG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007318201
20082—02
2009417102
2010421300
20116110012
20121013304
2013614625
20148177013
20151219609
20169131020
20179260297
20185150022
20199258010
202051221421
2021417009
2022921724
20239230013
202411182021
20259151018
202642470—

What is it indicated for?

The sterilization wrap (pouch) is a device intended to be used to enclose another medical device that is to be sterilized using ethylene oxide or steam by a health care provider. It is intended to allow sterilization via ethylene oxide or steam of the enclosed medical device and also to maintain sterility of the enclosed device until use.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Global Healthcare, Inc.

3 FDA decisions under this applicant name. See the company

  • K954549Surgical ApparelGlobal Healthcare, Inc. · 1996
  • K953754Global Healthcare Face MaskGlobal Healthcare, Inc. · 1996

Recent decisions in FRG

The FRG category page

  • K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap…O&M Halyard, Inc. · 2026
  • K252823Dukal Crepe Paper Sterilization WrapDukal, LLC · 2026
  • K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL…O&M Halyard, Inc. · 2026
  • K251347Sterilization Pouch/RollSterivic Medical Co., Ltd. · 2026
  • K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd. · 2025

https://510kreport.com/device/K990567 · printed Nov 5, 2026

Cite this page

510(k) Report. “K990567: Global Healthcare Self-Sealing Sterilization Pouch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990567

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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