Plasdent Disposable Barrier Sleeves and Barrier Film
Device Facts
| Record ID | K201604 |
|---|---|
| Device Name | Plasdent Disposable Barrier Sleeves and Barrier Film |
| Applicant | Plasdent Corporation |
| Product Code | PEM · General, Plastic Surgery |
| Decision Date | Dec 23, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4370 |
| Device Class | Class 2 |
Intended Use
Plasdent Disposable Barrier Sleeves and Barrier Film are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient one time use only.
Device Story
Disposable barrier sleeves and films made of polyethylene (PE) film; designed to cover dental instruments and equipment (e.g., trays, chairs, headrests, X-ray heads, computers, sensors, curing lights, handpieces). Used in dental clinics to provide a physical barrier against contamination during procedures. Operated by dental staff; applied manually to equipment. Acts as a protective layer to prevent cross-contamination between patients. Benefits include simplified cleaning/disinfection workflows and protection of equipment surfaces.
Clinical Evidence
No clinical data. Bench testing only, including biocompatibility (cytotoxicity, sensitization, irritation) and performance testing (tensile strength, puncture resistance, tear resistance, synthetic blood penetration, viral penetration) per ASTM standards.
Technological Characteristics
Materials: Polyethylene film (30% LDPE, 70% LLDPE). Form factor: Various pre-shaped sleeves and adhesive films. Non-sterile. Single-use. Standards: ASTM D882-18 (tensile), ASTM F1342 (puncture), ASTM D1004-13 (tear), ASTM F1670/F1671 (blood/viral penetration), ISO 10993-5/10 (biocompatibility).
Indications for Use
Indicated for use as a disposable barrier for dental instruments and equipment in a dental setting. Intended for single patient, one-time use.
Regulatory Classification
Identification
A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.
Special Controls
*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
Predicate Devices
- Pac-Dent Barrier Sleeve, Cover-It™ Barrier Film (K151123)
Related Devices
- K190484 — BH Medical Dental Barrier Sleeves and Barrier Film · Bh Medical Products Co., Ltd. · Sep 10, 2019
- K160232 — Disposable Barrier Sleeves and Covers · Dentsply International, Inc. · Jun 7, 2016
- K151123 — Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film · Pac-Dent International, Inc. · Mar 3, 2016
- K211026 — Minitube Dentasleeve Protective Barrier Sleeves · Minitube AB · Aug 3, 2021
- K163447 — Premium Plus Disposable Barrier Sleeve · Premium Plus International Limited · Jun 20, 2017
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
December 23, 2020
Plasdent Corporation Belen Walayat Corporate Manager 969 Price Street Pomona, California 91767
Re: K201604
Trade/Device Name: Plasdent Disposable Barrier Sleeves and Barrier Film Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape And Drape Accessories Regulatory Class: Class II Product Code: PEM Dated: November 18, 2020 Received: November 27, 2020
Dear Belen Walayat:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 0613012020 See PRA Statement below.
510(k) Number (if known) K201604
Device Name
Plasdent Disposable Barrier Sleeves and Barrier Film
Indications for Use (Describe)
Plasdent Disposable Barrier Sleeves and Barrier Film are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient one time use only.
| Model# | Description | Designed For |
|------------|------------------------------|-------------------------------------------------|
| PS201 | B Tray Sleeves w/ Lock Top | Dental Instrument Tray, 10-1/2" x 14" |
| PS202 | A Tray Sleeves w/ Lock Top | Dental Instrument Tray, 11-5/8" x 14-1/2" |
| PS204 | F Tray Sleeves w/ Lock Top | Dental Instrument Tray, 7-1/2" x 10-1/2" |
| PS3800 | Half Chair Covers or Sleeves | Half Dental Chair, 27-1/2"W x 24"L |
| PS3825 | Wide Half Chair Cover | Wide Half Chair, 32"W x 32"L |
| PS102 | Half Chair Cover | Half Chair, 24"W x 32"L |
| PS106 | Full Chair Covers or Sleeves | Wide Full Dental Chair, 44"W x 54"L |
| PS3850 | Full Chair Covers or Sleeves | X-Long Full Chair, 29"W x 80"L |
| PS650 | Headrest Cover | Headrest, 9-1/2"W x 11"W |
| PS660 | Headrest Cover | Large Headrest, 10"L x 14"W |
| PS1250C | Sticky Wraps (Barrier Film) | 4"W x 6"L, Clear Color |
| PS1250B | Sticky Wraps (Barrier Film) | 4"W x 6"L, Blue Color |
| PS400 | Computer Covers | Keyboard cover, 22"W x 14"L |
| PS400-S | Computer Covers | Small Keyboard, 12-1/2"W x 8"L |
| PF405 | Computer Covers | PC Mouse, Universal |
| PS410 | Computer Covers | LCD + Keyboard 22"W x 26"L |
| PS425 | Computer Covers | Laptop, 15-2/3"W x 24"L |
| PS1100 | X-ray Cover | X-ray 24"W x 32"L |
| PS1105 | X-ray Cover | X-ray, Universal, 15"W x 26"L |
| PS328P | Lite Handle Cover | Lite Handle for T-Style 5-3/4"W x 4"L |
| PS320A | Air/Water Syringe Covers | Air/Water Syringe, 3"W x 10"L |
| PS3720 | Air/Water Syringe Covers | Air/Water Syringe, Tube 2" Diameter |
| PS3740 | Air/Water Syringe Covers | Air/Water Syringe, Tube 4" Diameter |
| PS520 | Sensor Cover | #2 Sensor Cover, 1-5/8"W x 8-3/8"L |
| PS530 | Sensor Cover | #0 Sensor Cover, 1-3/8"W x 8-3/8"L |
| PS-SUNI-2 | X-ray Sensor Sheaths | For SUNI Size 2 Compatible TIDI: 20819 |
| PS-DEXIS-2 | X-ray Sensor Sheaths | For DEXIS Size 2 Compatible TIDI: 20999 |
| PS-6100-0 | X-ray Sensor Sheaths | For KODAK 6100 Size 0 Compatible TIDI:<br>20977 |
| PS-6100-1 | X-ray Sensor Sheaths | For KODAK 6100 Size 1 Compatible TIDI:<br>20978 |
| PS-6100-2 | X-ray Sensor Sheaths | For KODAK 6100 Size 2 Compatible TIDI:<br>20979 |
| PS-GXDR-1 | X-ray Sensor Sheaths | For GENDEX/XDR Size 1 |
| PS-GXDR-2 | X-ray Sensor Sheaths | For GENDEX/XDR Size 2 |
| PS-SHICK-1 | X-ray Sensor Sheaths | For SCHICK Size 1 Compatible TIDI: 20824 |
| PS-SHICK-2 | X-ray Sensor Sheaths | For SCHICK Size 2 Compatible TIDI: 20825 |
| PS4550 | Curing Light Sleeves | Curing Light Handle, 5"W x 10"L |
| PS4660 | Curing Light Sleeves | Complete Curing Light Handle, 3-1/4"W x<br>12"L |
| PS-DEMI | Curing Light Sleeves | Curing Light for DEMI |
| PS-LED | Curing Light Sleeves | LED Curing Light, 3-1/4"W x 12"L |
| PS700 | Handpiece Covers | Low Speed Long H.P., 1-1/2"W 7-1/2"L |
| PS710 | Handpiece Covers | Low Speed Contra-Angle, 8"W 3-1/2"L |
| PS720 | Handpiece Covers | High Speed, 1-1/6"W x 7-3/4"L |
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Type of Use (Select one or both, as applicable)
□ Prescription Use (Part 21 CFR 801 Subpart D)
网 Over-The-Counter Use
## (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE
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Image /page/5/Picture/0 description: The image shows the logo for Plasdent Corporation. The logo consists of a green square with a white shape inside, followed by the word "PLASDENT" in green, all caps. Below the word "PLASDENT" are two green lines, and below the lines is the word "CORPORATION" in smaller, green, all-caps letters.
# 510(K) Summary K201604
I. SUBMITTER: Plasdent Corporation 969 Price Street Pomona, CA 91767 Contact Person: Belen G. Walayat Title: Corporate Manager Phone: (909)620-0289*106 Email: belengw@plasdent.com Summary prepared: 01/30/2019 Summary revised: 08/19/2020
#### II. DEVICE
Name of Device: Plasdent Disposable Barrier Sleeves and Barrier Film Regulation Number: 21 CFR 878.4370 Common Name: Dental Barriers and Sleeves Classification Name: Surgical drape and drape accessories Regulatory Class: II Product Code: PEM
#### III. PREDICATE DEVICE
Predicate device: Pac-Dent Barrier Sleeve, Cover-It™ Barrier Film- K151123 Subject Device: Plasdent Disposable Barrier Sleeves and Barrier Film- K201604
#### IV. DEVICE DESCRIPTION
Plasdent Disposable Barrier Sleeves and Barrier Film are made of polyethylene film (PE), and come in various shapes and sizes as dental accessories intended to fit over and cover dental instruments and equipment. The Disposable Barrier Sleeves cover small hand-held dental instruments such as air/water syringes, curing lights, hand pieces, computers, sensors, dental instrument trays, and other similar handheld instruments to provide as a physical barrier or cover during a dental procedure. In other forms, the
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Disposable Barrier Film Covers are used to cover equipment, such as dental chairs, headrests, X-Ray heads, and other devices. The device is non-sterile, prepackaged, and is disposable, for single patient and one time use only.
#### V. INDICATIONS FOR USE
Plasdent Disposable Barrier Sleeves and Barrier Film are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
| Model# | Description | Designed For |
|---------|------------------------------|-------------------------------------------|
| PS201 | B Tray Sleeves w/ Lock Top | Dental Instrument Tray, 10-1/2" x 14" |
| PS202 | A Tray Sleeves w/ Lock Top | Dental Instrument Tray, 11-5/8" x 14-1/2" |
| PS204 | F Tray Sleeves w/ Lock Top | Dental Instrument Tray, 7-1/2" x 10-1/2" |
| PS3800 | Half Chair Covers or Sleeves | Half Dental Chair, 27-1/2"W x 24"L |
| PS3825 | Wide Half Chair Cover | Wide Half Chair, 32"W x 32"L |
| PS102 | Half Chair Cover | Half Chair, 24"W x 32"L |
| PS106 | Full Chair Covers or Sleeves | Wide Full Dental Chair, 44"W x 54"L |
| PS3850 | Full Chair Covers or Sleeves | X-Long Full Chair, 29"W x 80"L |
| PS650 | Headrest Cover | Headrest, 9-1/2"W x 11"W |
| PS660 | Headrest Cover | Large Headrest, 10"L x 14"W |
| PS1250C | Sticky Wraps (Barrier Film) | 4"W x 6"L, Clear Color |
| PS1250B | Sticky Wraps (Barrier Film) | 4"W x 6"L, Blue Color |
| PS400 | Computer Covers | Keyboard cover, 22"W x 14"L |
| PS400-S | Computer Covers | Small Keyboard, 12-1/2"W x 8"L |
| PF405 | Computer Covers | PC Mouse, Universal |
| PS410 | Computer Covers | LCD + Keyboard 22"W x 26"L |
| PS425 | Computer Covers | Laptop, 15-2/3"W x 24"L |
|------------|--------------------------|----------------------------------------------|
| PS1100 | X-ray Cover | X-ray 24"W x 32"L |
| PS1105 | X-ray Cover | X-ray, Universal, 15"W x 26"L |
| PS328P | Lite Handle Cover | Lite Handle for T-Style 5-3/4"W x 4"L |
| PS320A | Air/Water Syringe Covers | Air/Water Syringe, 3"W x 10"L |
| PS3720 | Air/Water Syringe Covers | Air/Water Syringe, Tube 2" Diameter |
| PS3740 | Air/Water Syringe Covers | Air/Water Syringe, Tube 4" Diameter |
| PS520 | Sensor Cover | #2 Sensor Cover, 1-5/8"W x 8-3/8"L |
| PS530 | Sensor Cover | #0 Sensor Cover, 1-3/8"W x 8-3/8"L |
| PS-SUNI-2 | X-ray Sensor Sheaths | For SUNI Size 2 Compatible TIDI: 20819 |
| PS-DEXIS-2 | X-ray Sensor Sheaths | For DEXIS Size 2 Compatible TIDI: 20999 |
| PS-6100-0 | X-ray Sensor Sheaths | For KODAK 6100 Size 0 Compatible TIDI: 20977 |
| PS-6100-1 | X-ray Sensor Sheaths | For KODAK 6100 Size 1 Compatible TIDI: 20978 |
| PS-6100-2 | X-ray Sensor Sheaths | For KODAK 6100 Size 2 Compatible TIDI: 20979 |
| PS-GXDR-1 | X-ray Sensor Sheaths | For GENDEX/XDR Size 1 |
| PS-GXDR-2 | X-ray Sensor Sheaths | For GENDEX/XDR Size 2 |
| PS-SHICK-1 | X-ray Sensor Sheaths | For SCHICK Size 1 Compatible TIDI: 20824 |
| PS-SHICK-2 | X-ray Sensor Sheaths | For SCHICK Size 2 Compatible TIDI: 20825 |
| PS4550 | Curing Light Sleeves | Curing Light Handle, 5"W x 10"L |
| PS4660 | Curing Light Sleeves | Complete Curing Light Handle, 3-1/4"W x 12"L |
| PS-DEMI | Curing Light Sleeves | Curing Light for DEMI |
| PS-LED | Curing Light Sleeves | LED Curing Light, 3-1/4"W x 12"L |
| PS700 | Handpiece Covers | Low Speed Long H.P., 1-1/2"W x 7-1/2"L |
| PS710 | Handpiece Covers | Low Speed Contra-Angle, 8"W x 3-1/2"L |
| PS720 | Handpiece Covers | High Speed, 1-1/6"W x 7-3/4"L |
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#### VI. TECHNOLOGICAL CHARACTERISTICS COMPARISON
The subject device, Plasdent Disposable Barrier Film, and the predicate device, Pac-Dent Barrier Sleeve, Cover-It™ Barrier Film, have the same intended use, which are used as protective barriers intended to fit over and cover dental instruments and equipment. Both the subject device and predicate device are made of same material, which is polyethylene film (PE). Both are non-sterile, prepackaged, disposable, and are for single patient and one time use only. The main slight difference between the subject and predicate device is the material composition. The polyethylene film of the subject device is composed of 30% low density polyethylene (LDPE) and 70% linear low density polyethylene (LLDPE), while the predicate device is composed of 20% low density polyethylene (LDPE) and 80% linear low density polyethylene (LLDPE). The difference is negligible & within acceptable range.
| DEVICE | Subject Device<br>Plasdent Disosable Barrier<br>Sleeves and Barrier Film<br>(K201604) | Primary Predicate Device<br>Pac-Dent Barrier Sleeve,<br>Cover-ItTM Barrier Film(K151123) | Comparison |
|----------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------|
| Intended Use | To be used as a barrier for dental<br>instruments and equipment. | To be used as a barrier for dental<br>instruments and equipment. | Same |
| Classification<br>Product Code | PEM | PEM | Same |
| Material | Polyethylene film | Polyethylene film | Same |
| Material<br>Composition | LLDPE (70%)<br>LDPE (30%)<br>Blue pigment<br>(item#PS1250B)<br>Adhesive (item#PS1250B,<br>PS1250C) | LLDPE(80%)<br>LDPE (20%)<br>Blue pigment<br>(item#100B, C101B)<br>Adhesive (item#C101, C101B) | Similar |
| Biocompatibility | Non-cytotoxic<br>Non-sensitizing<br>Non-irritating | Non-cytotoxic<br>Non-sensitizing<br>Non-irritating | Same |
| Specifications<br>and Tolerances | Paper backing: none<br>Film thickness:0.02-0.06mm<br>Tolerance: <0.01mm | Paper backing: some of the model<br>Film thickness:0.02-0.06mm<br>Tolerance: <0.01mm | Similar |
| Mechanical<br>Properties | Tensile Strength -ASTM D882-<br>Subject device is equivalent to<br>predicate device. | Tensile Strength -ASTM<br>D882 | Same<br>Pass |
| | Resistance to Puncture -ASTM<br>F1342-Subject device is equivalent<br>to predicate device. | Resistance to Puncture- ASTM<br>F1342 | Same<br>Pass |
| | Tear Strength – ASTM D1424-<br>Subject device is equivalent to<br>predicate device. | Tear Strength – ASTM<br>D1424 | Same<br>Pass |
| | Effectiveness of X-Ray and Sensor<br>Devices covered with Barrier<br>devices. | | Same<br>Pass |
| Performance<br>Properties | Synthetic Blood Penetration-<br>Pass | Synthetic Blood Penetration-<br>Pass | Same<br>Pass |
| Sterility | Non-sterile | Non-sterile | Same |
| Single Use | Single use device | Single use device | Same |
| FDA-Recognized<br>Standards | ASTM F1670 | ASTM F1670 | Same |
| | ASTM F1671 | ASTM F1671 | |
| | ASTM D882-18 | ASTM D882-18 | |
| | ASTM F1342 | ASTM F1342 | |
| | ASTM D1004-13 | ASTM D1004-13 | |
| | ISO 10993-5 | ISO 10993-5 | |
| | ISO 10993-10 | ISO 10993-10 | |
| | ISO 6988-13 | ISO 6988-13 | |
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Image /page/9/Picture/0 description: The image shows the logo for Plasdent Corporation. The logo consists of a green square with a white outline and a white shape inside. To the right of the square is the word "PLASDENT" in green, with the word "CORPORATION" in smaller green letters below it. The logo is simple and professional, and the green color suggests that the company is environmentally friendly.
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Image /page/10/Picture/0 description: The image shows the logo for Plasdent Corporation. The logo consists of a green square with a white square cut out of the top right corner. Below the square is the word "PLASDENT" in green, with the word "CORPORATION" in smaller green letters below that. The logo is simple and modern, and the green color gives it a sense of freshness and vitality.
#### VII. SUMMARY OF NON-CLINICAL TESTING
Shown below is the non-clinical testing performed with the subject device can meet the acceptance criteria referenced standard or test methodology shown in the table below:
| TEST | STANDARD | PURPOSE | ACCEPTANCE CRITERIA | RESULTS | RESULTS SUMMARY |
|------------------------------------------------------------------------------|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| BIOCOMPATIBILITY TESTING: | | | | | |
| In-Vitro Cytotoxicity | ANSI/AAMI/ISO<br>10993-5 | Evaluate the cytotoxicity of a test<br>article extract. | If viability is reduced to<br><70% of the blank, it has a<br>cytotoxic potential. | Text extract 100%: Viab. 79.10%<br>Test extract 75%: Viab. 83.72%<br>Test extract 50%: Viab. 88.91%<br>Test extract 25%: Viab. 94.10% | No cytotoxicity potential. |
| Sensitization | ISO 10993-10 | Evaluate the potential of the test<br>article to cause delayed dermal<br>contact sensitization in a guinea pig<br>maximization test. | Magnusson and Kligman<br>grades of 1 or greater in the<br>test group indicate<br>sensitization. | All dermal reactions for all<br>treatment groups over 24 and<br>48 hours: 0 | Not considered a sensitizer<br>in the guinea pig<br>maximization test. |
| Irritation | ISO 10993-10 | Evaluate the potential of the test<br>article to cause skin irritation<br>following application on the skin or<br>rabbits. | Cumulative irritation index<br>mean score >0.5 indicate<br>irritation. | Overall Test Group Mean: 0 | Irritation response category<br>of test article classified as<br>Negligible. |
| PERFORMANCE TESTING: | | | | | |
| Tensile Strength | ASTM D882-18 | Determine the tensile properties of<br>Subject device's disposable barrier<br>sleeve compared to that of Predicate<br>device disposable barrier sleeve. | Transverse: 35-45 MPa<br>Lengthways: 23-28 MPa | HL181201: T 39.46, L 26.26<br>HL20190601: T 39.84, L 26.46<br>HL20190605: T 40.32, L 26.52 | The tensile strength of both<br>products is in the same<br>range. |
| Puncture Resistance | ASTM F1342-05 | Determine the puncture resistance of<br>Subject device's disposable barrier<br>sleeve compared to that of Predicate<br>device's disposable barrier sleeve. | 4N-5N | 20190528: 4.56N<br>20190601: 4.58N<br>20190605: 4.56N | The puncture resistance of<br>both products is in the same<br>range. |
| Tear Resistance | ASTM D1004-<br>13 | Determine the tear resistance of<br>Subject device's disposable barrier<br>sleeve compared to that of Predicate<br>device's disposable barrier sleeve. | 4N-6N | HL20190605: 5.026N<br>HL20190610: 5.046N<br>HL20190615: 5.032N | The tear resistance of both<br>products is in the same<br>range. |
| Synthetic Blood<br>Penetration | ASTM<br>F1670 | Evaluate the resistance of test<br>material to penetration by synthetic<br>blood under conditions of continuous<br>liquid contact. | Pass determination based<br>on no visual detection of<br>synthetic blood<br>penetration. | Material: no synthetic blood<br>penetration seen | Pass. Test material resistant<br>to synthetic blood<br>penetration. |
| Synthetic blood<br>penetration at<br>seams and non-<br>continuous components | ASTM<br>F1670 | Evaluate the resistance of test<br>material at seams to penetration by<br>synthetic blood under conditions of<br>continuous liquid contact. | Pass determination based<br>on no visual detection of<br>synthetic blood<br>penetration. | Material seams: no synthetic<br>blood penetration seen | Pass. Test material seams<br>resistant to synthetic blood<br>penetration. |
| Viral Penetration | ASTM<br>F1671 | Evaluate the barrier performance of<br>test material which are intended to<br>protect against blood borne pathogen<br>hazards. | Pass determination based<br>on no visual detection of<br>viral penetration and assay<br>titer value <1 ° | Visual penetration: none seen<br>Assay Titer (PFU/mL): <1° | Pass. Test material<br>successfully protects against<br>blood borne pathogen<br>hazards. |
| Viral Penetration at<br>seams and non-<br>continuous components | ASTM<br>F1671 | Evaluate the barrier performance of<br>test material at seams which are<br>intended to protect against blood<br>borne pathogen hazards. | Pass determination based<br>on no visual detection of<br>viral penetration and assay<br>titer value <1° | Visual penetration: none seen<br>Assay Titer (PFU/mL): <1° | Pass. Test material seam<br>successfully protects against<br>blood borne pathogen<br>hazards. |
| Thickness | ASTM D6988-13 | Determine the thickness of test<br>material. | N/A | 0.018mm | Thickness: 0.018mm |
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Image /page/11/Picture/0 description: The image shows the logo for Plasdent Corporation. The logo consists of a green square with a white design inside, next to the word "PLASDENT" in green, with the word "CORPORATION" in smaller green letters below it. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products.
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Image /page/12/Picture/0 description: The image contains a logo for PLASDENT CORPORATION. The logo consists of a green geometric shape on the left, followed by the text "PLASDENT" in a larger, bolder font. Below "PLASDENT", the word "CORPORATION" is written in a smaller font. The overall design is simple and professional, likely representing a corporate identity.
## Clinical Performance Data
No needed for this device.
# VIII. CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the Plasdent Disposable Barrier Sleeves and Barrier Films device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the Pac-Dent Barrier Sleeve cleared under K151123, Class II (21 CFR 878.4370), product code PEM.
