2026 data FDA MAUDE openFDA FDA Class I

Latex Patient Examination Glove

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 §880.6250 (General Hospital panel).

FDA MAUDE casebook

openFDA event book Latex Patient Examination Glove LIGHT-BOOK · MAUDE

#409 of 1000 · 2,992 reports · 1992–2026

  • BOOK 2,992 reports
  • RANK #409 of 1000
  • DEATH 17 death-typed
  • INJ 1,087 injury-typed
  • MALF 103 malfunction
  • SPAN 1992–2026
  • PEAK 1999: 691
  • PHOTO Medical Device Data S…

Nearest event-volume peer: Medical Device Data System (11 report gap)

Latex Patient Examination Glove sits #409 of 1000 among tracked device types with 2,992 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

Latex Patient Examination Glove carries 3.4% MALFUNCTION-coded reports, 61.4pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 36.3% corpus 30.3% · above corpus mean (+6.0 pp)
  • MALF 3.4% corpus 64.8% · below corpus mean (-61.4 pp)

Lead product-problem code Reaction is 81% of coded problems · Lead manufacturer UNK accounts for 63% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Latex Patient Examination Glove in the event-volume neighbourhood

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

reports

What this shows Latex Patient Examination Glove carries 2,992 MAUDE reports, ranked #409 of 1000.

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

Event Types

Other 1,688 (56.4%)
Injury 1,087 (36.3%)
Malfunction 103 (3.4%)
97 (3.2%)
Death 17 (0.6%)

Patient Outcomes

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

Other 1,823 (55.7%)
Disability 456 (13.9%)
290 (8.9%)
Required Intervention 179 (5.5%)
Life Threatening 152 (4.6%)
S 98 (3.0%)
R 88 (2.7%)
Hospitalization 72 (2.2%)
L 49 (1.5%)
O 40 (1.2%)
Death 17 (0.5%)
Invalid Data 6 (0.2%)
H 3 (0.1%)
Not Applicable 2 (0.1%)

Top Product Problems

Reaction 2,098
Unknown (for use when the device problem is not known) 234
Tears, rips, holes in device, device material 43
Other (for use when an appropriate device code cannot be identified) 32
Product Quality Problem 20
Replace 20
Hole In Material 16
Adverse Event Without Identified Device or Use Problem 15
Normal 14
Foreign material 10
Out-Of-Box Failure 10
Misassembled 9
Insufficient Device Problem Information 8
Leak/Splash 8
Patient-Device Incompatibility 8
Sticking 7
Design/structure problem 6
Device Contamination with Chemical or Other Material 6
Material Split, Cut or Torn 6
Break 5

Yearly Trend

92
1992: 7
93
1993: 7
94
1994: 106
95
1995: 68
96
1996: 184
97
1997: 374
98
1998: 599
99
1999: 691
00
2000: 429
01
2001: 278
02
2002: 88
03
2003: 24
04
2004: 18
05
2005: 12
06
2006: 6
07
2007: 11
08
2008: 14
09
2009: 11
10
2010: 10
11
2011: 4
12
2012: 1
13
2013: 2
14
2014: 6
15
2015: 5
16
2016: 7
17
2017: 7
19
2019: 7
20
2020: 1
21
2021: 1
24
2024: 6
25
2025: 1
26
2026: 7

Reports fell to 1 in 2025, down from an average of 4 in the two years before.

Related Entities for Latex Patient Examination Glove

Top Manufacturers

UNK 151
UNKNOWN 88

Event Locations

1,630 (54.5%)
UNKNOWN 557 (18.6%)
HOSPITAL 381 (12.7%)
INVALID DATA 151 (5.0%)
OTHER 104 (3.5%)
NO INFORMATION 50 (1.7%)
OUTPATIENT TREATMENT FACILITY 44 (1.5%)
OUTPATIENT DIAGNOSTIC FACILITY 16 (0.5%)
HOME 15 (0.5%)
NURSING HOME 13 (0.4%)
PUBLIC VENUE 10 (0.3%)
NOT APPLICABLE 5 (0.2%)
I 3 (0.1%)
PUBLIC BUILDING 3 (0.1%)
AMBULATORY SURGICAL FACILITY 2 (0.1%)
DIALYSIS CENTER 1 (0.0%)
EMERGENCY ROOM 1 (0.0%)
LABORATORY 1 (0.0%)
LABORATORY/PATHOLOGY DEPARTMENT 1 (0.0%)
OUTDOORS 1 (0.0%)
PATIENT'S ROOM OR WARD 1 (0.0%)
SCHOOL 1 (0.0%)
STREET 1 (0.0%)

Compare UNK vs UNKNOWN →

Nationwide devices with a comparable volume-and-death footprint

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

Disclaimer: MAUDE figures for Latex Patient Examination Glove 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 Latex Patient Examination Glove; 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.