# Kimberly-Clark Corp.

- Location (FDA's records): Roswell, GA
- FDA decisions: 122 (1978–2023): 122 510(k) clearances
- Names in FDA's records: Kimberly-Clark Corp. (104); Kimberly-Clark Corporation (11); Kimberly-Clark (5); Kimberly Clark Corporation (2)
- Product codes: HEB (16), HHD (13), FYA (12), LZA (11), FRG (11), KKX (8), HHL (7), BTR (4), FXX (4), KME (3), KGC (2), KNT (2)
- 510(k) review time since 2016: median 98 days, against 101 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 69 (41 its own); citations of its devices by later devices: 140 (41 its own)
- Recalls linked to its devices: 25 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Safeskin Corp.: 5 (https://510kreport.com/company/safeskin)
- Medical Innovations Corp.: 3 (https://510kreport.com/company/medical-innovations)
- Vitaid, Ltd.: 2 (https://510kreport.com/company/vitaid)
- Promedical Products Co., Ltd.: 2 (https://510kreport.com/company/promedical-products)
- Ballard Medical Products: 2 (https://510kreport.com/company/ballard-medical-products)
- Crosstex International: 2 (https://510kreport.com/company/crosstex-international)
- I-Flow Corp.: 1 (https://510kreport.com/company/i-flow)
- Life-Tech, Inc.: 1 (https://510kreport.com/company/life-tech)

## Firms that cite its devices most
- Halyard Health, Inc.: 8 (https://510kreport.com/company/halyard-health)
- Owens & Minor (O&M) Halyard, Inc.: 7 (https://510kreport.com/company/owens-minor-o-m-halyard)
- Kimberly-Clark Health Care: 7 (https://510kreport.com/company/kimberly-clark-health-care)
- Cardinal Health200, LLC: 7 (https://510kreport.com/company/cardinal-health200)
- Ahlstrom Nonwovens, LLC: 5 (https://510kreport.com/company/ahlstrom-nonwovens)
- O&M Halyard, Inc.: 4 (https://510kreport.com/company/o-m-halyard)
- Gri Medical & Electronic Technology Co., Ltd.: 3 (https://510kreport.com/company/gri-medical-electronic-technology)
- Medline Industries, Inc.: 3 (https://510kreport.com/company/medline-industries)

## Its most-cited devices
- K110455: Kimberly-Clark Low Barrier, Astm 2100 Face Masks (2011), cited by 19
- K082177: Kimguard One-Step Sterilization Wrap (2009), cited by 9
- K111402: KC200, Surgical Mask, KC200, Procedure Mask, KC300, Surgicalmask, Fluidshield, KC300, Procedure Mask, Fluidshield Model (2011), cited by 9
- K092167: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600 (2009), cited by 7
- K081260: Kimberly-Clark *Lavender* Nitrile Power-Free Exam Gloves (2008), cited by 5
- K080795: Ultra Surgical Gown & Fluid Barrier Surgical Gown (2008), cited by 5

## Recent decisions
- K231435: KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Aug 28, 2023)
- K231021: KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Jul 21, 2023)
- K223749: U by Kotex® Click®  Unscented Menstrual Tampons (Jan 6, 2023)
- K202416: Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Nov 30, 2020)
- K200072: KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid (Apr 10, 2020)
- K172118: U by Kotex Click Unscented Menstrual Tampons (Oct 11, 2017)
- K143164: ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set (Dec 2, 2014)
- K140963: Kimguard Smart-Fold Sterilization Wrap (Nov 10, 2014)

Source page: https://510kreport.com/company/kimberly-clark