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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drape, surgical, antimicrobial
Regulation Description Surgical drape and drape accessories.
Definition Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.
Product CodeKKX
Regulation Number 878.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
AVERY DENNISON BELGIE BVBA
  SUBSTANTIALLY EQUIVALENT 1
AVERY DENNISON MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 41 41
2022 19 19
2023 32 32
2024 19 19
2025 24 24
2026 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 15 15
Human-Device Interface Problem 11 11
Material Puncture/Hole 7 7
Material Split, Cut or Torn 7 7
Appropriate Device Problem Term/Code Not Available 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Patient Device Interaction Problem 4 4
Insufficient Device Problem Information 3 3
Improper or Incorrect Procedure or Method 3 3
Detachment of Device or Device Component 3 3
Device Damaged Prior to Use 2 2
Adhesive Too Strong 2 2
Break 2 2
Component Misassembled 1 1
Use of Device Problem 1 1
Contamination /Decontamination Problem 1 1
Unsealed Device Packaging 1 1
Degraded 1 1
Physical Resistance/Sticking 1 1
Contamination 1 1
Component Incompatible 1 1
Component Missing 1 1
Material Perforation 1 1
Blocked Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 70 70
Skin Tears 31 31
Pain 14 14
Insufficient Information 14 14
Erythema 12 12
Blister 11 11
Burning Sensation 7 7
Skin Inflammation/ Irritation 7 7
Swelling/ Edema 7 7
Skin Burning Sensation 5 5
Foreign Body In Patient 4 4
Exposure to Body Fluids 3 3
Burn(s) 3 3
Wound Dehiscence 2 2
Laceration(s) 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Full thickness (Third Degree) Burn 2 2
Unspecified Infection 2 2
Hypersensitivity/Allergic reaction 2 2
Failure of Implant 1 1
Device Embedded In Tissue or Plaque 1 1
No Consequences Or Impact To Patient 1 1
Bacterial Infection 1 1
Contact Dermatitis 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Local Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
2 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
5 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
7 Medline Industries, LP II May-07-2026
8 Medline Industries, LP II Apr-17-2026
9 Medline Industries, LP II Feb-17-2026
10 O&M HALYARD INC II Sep-04-2025
11 O&M HALYARD, INC. II Jan-17-2025
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