MEDLINE ADMISSION KITS
Device Facts
| Record ID | K965107 |
|---|---|
| Device Name | MEDLINE ADMISSION KITS |
| Applicant | Medline Industries, Inc. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Mar 11, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Intended Use
Medline Personal Protection Kits are intended for use by, but not limited to, hospitals and medical centers. The original intended use of the medical products assembled in these kits will not be changed.
Device Story
Medline Employee Protection Kit is an assemblage of medical and non-medical items designed to protect employees from body fluids or hazardous materials. Kits are custom-configured by customers, who specify contents, quantities, and brands of individual components. The device is non-sterile and shrink-wrapped to maintain integrity. It is used in clinical settings (hospitals, medical centers) by employees. The kit does not alter the intended use of the individual medical devices contained within. Benefit is derived from the convenience of having pre-assembled protective equipment available for immediate use in hazardous situations.
Clinical Evidence
No clinical data. Bench testing only.
Technological Characteristics
Non-sterile, shrink-wrapped kit containing various medical and non-medical protective items (e.g., masks, gloves, gowns, shoe covers). No specific materials or standards cited beyond component regulatory status. No electronic, software, or algorithmic components.
Indications for Use
Indicated for use by employees in hospitals and medical centers requiring protection from body fluids or other potentially hazardous situations.
Regulatory Classification
Identification
Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
Special Controls
*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Predicate Devices
- EZ Personal Protection Kit (K952962)
Reference Devices
Related Devices
- K964168 — PROCEDURE SPECIFIC KITS · Sage Products, Inc. · Mar 3, 1997
- K212258 — Medline Cardiovascular Procedure Kit · Medline Industries, Inc. · Dec 3, 2021
- K971062 — OPPORTUNITY INC. GENERAL PURPOSE TRAY · Opportunity, Inc. · Jun 9, 1997
- K955417 — VITAL PAK · Vital Signs, Inc. · Mar 8, 1996
- K961683 — JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY · J.J. Skinner, Inc. · May 10, 1996
