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Barrier Supreme Surgical Drape

Model 96601092 · STANDARD TEXTILE CO., INC. · DI 00634916186697

PUI — Drape, Surgical, Exempt · Class II · 21 CFR 878.4370

UDILibrary device dossier · generated 2026-09-06 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

61117232019-03: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 6/device2019-08: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 2.5/device2020-08: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 3/device2021-04: 0 reports for this device; peer average 1.5/device2021-05: 0 reports for this device; peer average 3/device2021-06: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 1.5/device2022-12: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 1.5/device2023-06: 0 reports for this device; peer average 2.33/device2023-07: 0 reports for this device; peer average 2.5/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 1.5/device2024-04: 0 reports for this device; peer average 1.5/device2024-05: 0 reports for this device; peer average 1.25/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 3.5/device2024-08: 0 reports for this device; peer average 4/device2024-09: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 3/device2024-12: 0 reports for this device; peer average 2.67/device2025-01: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1.67/device2025-05: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 3/device2025-09: 0 reports for this device; peer average 2.33/device2025-11: 0 reports for this device; peer average 3.25/device2025-12: 0 reports for this device; peer average 4.33/device2026-01: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 3.63/device2026-03: 0 reports for this device; peer average 22.8/device2026-04: 0 reports for this device; peer average 9.4/device2026-05: 0 reports for this device; peer average 5/device2026-06: 0 reports for this device; peer average 3.2/device030708100304070811030405060911120608101112020304060709101203040506070809111201020305060708091112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0302
2019-0706
2019-0801
2019-1001
2020-0301
2020-0401
2020-0702.5
2020-0801
2020-1101
2021-0303
2021-0401.5
2021-0503
2021-0602
2021-0901
2021-1101
2021-1203
2022-0601
2022-0801
2022-1002
2022-1101.5
2022-1201
2023-0201
2023-0301
2023-0401.5
2023-0602.33
2023-0702.5
2023-0901
2023-1001
2023-1202
2024-0301.5
2024-0401.5
2024-0501.25
2024-0602
2024-0703.5
2024-0804
2024-0902
2024-1103
2024-1202.67
2025-0101
2025-0201
2025-0301.67
2025-0501
2025-0602
2025-0702
2025-0803
2025-0902.33
2025-1103.25
2025-1204.33
2026-0102
2026-0203.63
2026-03022.8
2026-0409.4
2026-0505
2026-0603.2
This device (reports/month)Average device in PUI (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — STANDARD TEXTILE CO., INC.

  • Warning Letter 2013-05-07 Standard Textile Co Inc
  • Warning Letter 2013-05-07 Standard Textile Co Inc
  • NAI 2023-07-12 Standard Textile Co Inc · 0 citations
  • NAI 2023-07-12 Standard Textile Co Inc · 0 citations
  • VAI 2020-02-28 Standard Textile Co Inc · 3 citations
  • VAI 2020-02-28 Standard Textile Co Inc · 3 citations
  • VAI 2016-10-14 Standard Textile Co Inc · 3 citations
  • VAI 2016-10-14 Standard Textile Co Inc · 3 citations
  • NAI 2014-05-13 Standard Textile Co Inc · 0 citations
  • NAI 2014-05-13 Standard Textile Co Inc · 0 citations
  • OAI 2013-02-08 Standard Textile Co Inc · 1 citations
  • OAI 2013-02-08 Standard Textile Co Inc · 1 citations