2026 data FDA MAUDE openFDA FDA Class I

Polymer 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 Polymer Patient Examination Glove LIGHT-BOOK · MAUDE

#810 of 1000 · 635 reports · 1997–2026

  • BOOK 635 reports
  • RANK #810 of 1000
  • DEATH 0 death-typed
  • INJ 134 injury-typed
  • MALF 471 malfunction
  • SPAN 1997–2026
  • PEAK 2026: 272
  • PHOTO Instrument

Nearest event-volume peer: Instrument, Ligature Passing And Knot Tying (0 report gap)

Polymer Patient Examination Glove sits #810 of 1000 among tracked device types with 635 MAUDE reports spanning 1997–2026. 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 run above the device-type norm

Polymer Patient Examination Glove carries 74.2% MALFUNCTION-coded reports, 9.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 21.1% corpus 30.3% · below corpus mean (-9.2 pp)
  • MALF 74.2% corpus 64.8% · above corpus mean (+9.3 pp)

Lead product-problem code Material Split, Cut or Torn is 46% of coded problems · Lead manufacturer MEDLINE INDUSTRIES, LP accounts for 76% of manufacturer-tagged reports · Top event location is 67% of location-tagged rows .

Polymer Patient Examination Glove in the event-volume neighbourhood

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

reports

What this shows Polymer Patient Examination Glove carries 635 MAUDE reports, ranked #810 of 1000.

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

Event Types

Malfunction 471 (74.2%)
Injury 134 (21.1%)
Other 26 (4.1%)
4 (0.6%)

Patient Outcomes

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

455 (72.1%)
Other 155 (24.6%)
Required Intervention 9 (1.4%)
R 5 (0.8%)
O 3 (0.5%)
Disability 2 (0.3%)
Congenital Anomaly 1 (0.2%)
Hospitalization 1 (0.2%)

Top Product Problems

Material Split, Cut or Torn 251
Material Puncture/Hole 36
Patient-Device Incompatibility 30
Torn Material 27
Adverse Event Without Identified Device or Use Problem 23
Break 20
Material Integrity Problem 20
Defective Device 17
Product Quality Problem 15
Contamination 14
Device Contamination with Chemical or Other Material 13
Hole In Material 12
Patient Device Interaction Problem 12
Insufficient Device Problem Information 11
Physical Resistance/Sticking 9
Unknown (for use when the device problem is not known) 9
Material Discolored 8
Component Incompatible 7
Component Missing 7
Device Contaminated During Manufacture or Shipping 7

Yearly Trend

97
1997: 1
00
2000: 1
03
2003: 1
04
2004: 1
05
2005: 4
06
2006: 3
07
2007: 7
08
2008: 2
09
2009: 12
10
2010: 12
11
2011: 9
12
2012: 11
13
2013: 10
14
2014: 8
15
2015: 12
16
2016: 25
17
2017: 4
18
2018: 3
19
2019: 21
20
2020: 4
21
2021: 20
22
2022: 19
23
2023: 24
24
2024: 76
25
2025: 73
26
2026: 272

Reports rose to 73 in 2025, up from an average of 50 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Polymer Patient Examination Glove

Event Locations

428 (67.4%)
HOSPITAL 114 (18.0%)
OTHER 45 (7.1%)
NO INFORMATION 20 (3.1%)
I 16 (2.5%)
OUTPATIENT TREATMENT FACILITY 6 (0.9%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
HOME 1 (0.2%)
IN TRANSIT TO USER/MEDICAL FACILITY 1 (0.2%)
NOT APPLICABLE 1 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)
PUBLIC VENUE 1 (0.2%)

Compare MEDLINE INDUSTRIES, LP vs CARDINAL HEALTH →

Nationwide devices with a comparable report-volume footprint

Polymer Patient Examination Glove carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (635 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Polymer 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 Polymer 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.