COMPLEAT SURGICAL MASK

K962654 · Carl Parker Associates, Inc. · FXX · Jan 27, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K962654
• Device Name: COMPLEAT SURGICAL MASK
• Applicant: Carl Parker Associates, Inc.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jan 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

to act as physical barrier including fluid-resistant properties, provide only very low impediment to breathing, avoid fogging of surgeons' glasses, effective filtration of particles, droplets, not hinder speech.

Device Story

Disposable surgical mask; three-layer construction; non-woven polypropylene outer/inner layers; 'Web Dynamics' air filtration media middle layer. Designed for nose/mouth coverage; flat-fold arcuate segment design. Used in clinical/surgical settings by healthcare personnel. Functions as physical barrier; provides fluid resistance; minimizes spectacle fogging; facilitates breathing. Benefits patient/clinician by reducing exposure to airborne particles and body fluids during procedures.

Clinical Evidence

Bench testing only. Testing included Synthetic Blood Penetration Resistance (Protocol 9617002-01), Bacterial Filtration Efficiency (BFE), Delta P, Primary Dermal Irritation, Particulate Shedding analysis, flammability, and cytotoxicity.

Technological Characteristics

Three-layer flat-fold design; non-woven polypropylene layers; 'Web Dynamics' air filtration media. Disposable. No energy source. No software.

Indications for Use

Indicated for use as a surgical mask to provide a physical barrier against fluids, particles, and droplets for clinicians and surgical staff.

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

• Fluid Resistant Masks, Busse Hosp Disposables (K830890)
• Fluid Shield Procedure Mask, Technol Inc. (K932137)
• Fluid Resistant Mask, Mid America Medical, Inc. (K934974)

Submission Summary (Full Text)

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Jan-17-97 03:15P 516-434-7750- P.02

JAN 27 1997

XII. SAFE MEDICAL DEVICES ACT OF 1990 SUMMARY OF SAFETY AND EFFECTIVENESS. Jan. 16, 1997. [Separate Pages] K962657

A. Submitter Andrew Parker, Car Parker Assoc. Inc., 275 Oser Ave., Hauppauge, NY 11788

I. Classification Names and numbers. Surgical Mask, 79FXX

II. Common/Usual Name. Surgical Mask

III. Proprietary Names. Conpleat! Surgical Mask

IV. Establishment Registration Number. 2433028

V. Classification. Surgical masks were classified by the General and Plastic Surgery Panel in Class II under code 79FXX and are listed in CFR 878 4040 as "Surgical Apparel". Most examples are Class I except for surgical gowns and masks which are Class II

VI. Performance Standard. None established under section 514.

VII. Description of the Device. These disposable surgical masks are formed of three layers and are flat-fold disposable face masks comprised of two arcuate segments which form a comfortable mask covering the nose and mouth areas of the face. The outer mask surface is of non-woven polypropylene. The middle layer, between the non-woven outer and inner layers, is made of "Web Dynamics" air filtration media. This material is designed as a highly efficient bacterial filter with very low pressure drop, to facilitate breathing and minimize spectacle fogging. The facial layer is of non-woven polypropylene. The mask is designed to be resistant to penetration even when body fluids strike it with impact, while allowing cool, comfortable breathing.

VIII. Labels of the product and competitive devices are provided

IX. Substantial Equivalence Statement. The "510(k)" "Substantial Equivalence" Decision process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

1. These products have the same intended use, to act as physical barrier including fluid-resistant properties, provide only very low impediment to breathing, avoid fogging of surgeons' glasses, effective filtration of particles, droplets, not hinder speech. These are the same as those of the predicate devices. These products also have the same intended uses as similar products currently cleared for marketing by the 510(k) process.

2. The technological characteristics for this product are the same as those for the predicate devices and those currently on the market.

3. Descriptive information provided shows that the materials from which the Conpleat Surgical Mask is made are substantially equivalent to (nearly identical with) those of similar products, used for identical purposes, currently on the market.

4. Test data supplied to show the equivalence of this device to Techinol and others cited below included

a. Synthetic Blood Penetration Resistance Test, Protocol 9617002-01 selected as more definitive than Penetration by Water Impact Test.

b. Bacterial Filtration Efficiency and Delta P tests;

c. Primary Dermal Irritation test.

d. Particulate Shedding analysis, flammability, and

e. Cytotoxicity

Repl. p 8

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Jan-21-97 01:42P
516-434-7750-
P.03

4 The FDA "Decision-Making Process" chart was used.

The Conpleat Surgical Mask is substantially equivalent to the originally classified device, described under CFR 878 4040, to preamendment devices and to devices currently on the market, cleared by the 510(k) process. The Conpleat Surgical Mask is substantially equivalent to (for example) the following devices: Software, Fluid Resistant Masks, Busse Hosp Disposables, K-830890, Fluid Shield Procedure Mask, Technol Inc., K-9321375, Fluid Resistant Mask, Mid America Medical, Inc., K-934974.

End of Summary

Repl. p. 8a