Regulatory & Compliance Information
Biocompatibility Rationale: Cokach Disposable Applicator
1. Device Identification
Product Name: Cokach Disposable Applicator
Description: Single-use, non-sterile disposable cream applicator.
Primary Material: Recycled Cellulose.
Intended Use: External application of topical creams to intact skin.
2. Justification for Waiver of ISO 10993 Testing
In accordance with FDA Guidance: Use of International Standard ISO 10993-1 (Attachment G), formal biological testing is omitted based on the following safety profile:
Material Composition: The Cokach Disposable Applicator is manufactured from recycled Cellulose, a natural fiber with a long-standing history of safe use in legally marketed medical devices and consumer products.
Contact Classification: The device is categorized as a Surface Device in contact with Intact Skin only.
Contact Duration: The duration of contact is Limited (Category A), typically lasting less than 10 minutes per application ("once and done").
Manufacturing Controls: The recycled cellulose material is sourced and manufactured under strict controls to ensure it is free from novel chemical coatings, toxic additives, or heavy metals. No hazardous colorants or adhesives are used in the final construction.
3. Conclusion
Based on the transient nature of the skin contact and the well-characterized safety of cellulose, the Cokach Disposable Applicator poses a negligible risk for cytotoxicity, irritation, or sensitization. Therefore, specialized ISO 10993 laboratory testing (Parts 5, 10, and 23) is stated -not required to demonstrate biological safety for its intended use.
FDA Label Information and intent-to-comply. Device exempt.
Cokach™ Disposable Applicator
For External Application of Topical Creams to Intact Skin, Mixing formulations.
Contains 40 Disposable Applicators
Manufactured in U.S.A. by: Cokach™ Medical
Lot: Display label
Exp: Display label
Directions for Use
- Apply cream to applicator end.
- Spread evenly over affected area.
- Discard after single use.
Warnings
- For External Use Only
- Single Use Only — Discard After Use
- Do Not Use on Broken or Irritated Skin
- Non-Sterile
Note: Each applicator may exhibit slight variations in size due to proprietary manufacturing process. Variations do not affect applicator performance when used as directed.
Applicator manufactured from sustainably sourced, recycled cellulose.
Contact: salescokachmedical@gmail.com