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2026 data FDA MAUDE openFDA FDA Class I

Surgeon'S Gloves

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4460 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Surgeon'S Gloves LIGHT-BOOK · MAUDE

#748 of 1000 · 770 reports · 1992–2026

  • BOOK 770 reports
  • RANK #748 of 1000
  • DEATH 2 death-typed
  • INJ 183 injury-typed
  • MALF 342 malfunction
  • SPAN 1992–2026
  • PEAK 2026: 111
  • PHOTO Surgical Device

Nearest event-volume peer: Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue (0 report gap)

Surgeon'S Gloves sits #748 of 1000 among tracked device types with 770 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports sit below the device-type norm

Surgeon'S Gloves carries 44.4% MALFUNCTION-coded reports, 20.4pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 23.8% corpus 30.3% · below corpus mean (-6.5 pp)
  • MALF 44.4% corpus 64.8% · below corpus mean (-20.4 pp)

Lead product-problem code Reaction is 16% of coded problems · Lead manufacturer CARDINAL HEALTH accounts for 72% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Surgeon'S Gloves in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Surgeon'S Gloves carries 770 MAUDE reports, ranked #748 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 342 (44.4%)
Other 224 (29.1%)
Injury 183 (23.8%)
19 (2.5%)
Death 2 (0.3%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Other 400 (50.2%)
276 (34.6%)
Required Intervention 54 (6.8%)
Life Threatening 19 (2.4%)
R 16 (2.0%)
Hospitalization 13 (1.6%)
S 7 (0.9%)
O 4 (0.5%)
L 3 (0.4%)
Death 2 (0.3%)
H 1 (0.1%)
Congenital Anomaly 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Reaction 102
Material Split, Cut or Torn 99
Unknown (for use when the device problem is not known) 81
Insufficient Device Problem Information 40
Material Puncture/Hole 38
Material Integrity Problem 25
Tears, rips, holes in device, device material 24
Adverse Event Without Identified Device or Use Problem 23
Torn Material 23
Break 19
Hole In Material 19
Device Contamination with Chemical or Other Material 17
Material Separation 17
Patient-Device Incompatibility 17
Material Fragmentation 16
Other (for use when an appropriate device code cannot be identified) 16
Product Quality Problem 14
Fluid/Blood Leak 11
Inadequacy of Device Shape and/or Size 10
Material Discolored 10

Yearly Trend

92
1992: 2
93
1993: 11
94
1994: 17
95
1995: 8
96
1996: 24
97
1997: 38
98
1998: 66
99
1999: 38
00
2000: 24
01
2001: 9
02
2002: 7
03
2003: 8
04
2004: 11
05
2005: 15
06
2006: 15
07
2007: 13
08
2008: 8
09
2009: 14
10
2010: 16
11
2011: 14
12
2012: 14
13
2013: 41
14
2014: 28
15
2015: 11
16
2016: 15
17
2017: 20
18
2018: 15
19
2019: 51
20
2020: 15
21
2021: 14
22
2022: 10
23
2023: 28
24
2024: 18
25
2025: 21
26
2026: 111

Reports in 2025 (21) held close to the prior two-year average of 23.

Related Entities for Surgeon'S Gloves

Top Manufacturers

CARDINAL HEALTH 119
MEDLINE INDUSTRIES, LP 47

Event Locations

441 (57.3%)
HOSPITAL 192 (24.9%)
I 44 (5.7%)
NO INFORMATION 38 (4.9%)
UNKNOWN 16 (2.1%)
OUTPATIENT TREATMENT FACILITY 13 (1.7%)
OTHER 11 (1.4%)
INVALID DATA 10 (1.3%)
AMBULATORY SURGICAL FACILITY 2 (0.3%)
NOT APPLICABLE 2 (0.3%)
OPERATING ROOM 1 (0.1%)

Compare CARDINAL HEALTH vs MEDLINE INDUSTRIES, LP →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Surgeon'S Gloves: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (770 here).

Surgical Device 770 Electrosurgical 772 Adhesive 773 Gas Control Unit, Cardiopulmonary Bypass 767

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Surgeon'S Gloves are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Surgeon'S Gloves; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.