UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope

K183263 · Unipack Medical Corporation · PEM · Jun 14, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K183263
• Device Name: UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
• Applicant: Unipack Medical Corporation
• Product Code: PEM · General, Plastic Surgery
• Decision Date: Jun 14, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope are intended to be used as a barrier to cover dental instruments. This device is non-sterile and intended for single patient use only.

Device Story

Device consists of polyethylene (LLDPE/LDPE) sleeves and films in various shapes/sizes; used to cover dental instruments, equipment, and surfaces (e.g., chairs, trays, x-ray heads, sensors, handpieces). Function is purely mechanical barrier protection; prevents cross-contamination between patients and dental equipment. Used in dental clinics by dental staff. No active components; no electronic input/output. Benefits patient by reducing risk of pathogen transmission during dental procedures.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM standards for synthetic blood penetration (F1670), blood-borne pathogen penetration (F1671), tensile properties (D882), puncture resistance (F1342), and tear resistance (D1004). Biocompatibility confirmed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization). X-ray effectiveness validated via side-by-side visual comparison of images taken with and without barriers, showing no observable difference.

Technological Characteristics

Materials: 80% LLDPE, 20% LDPE. Film thickness: 0.02-0.06mm. Form factor: various pre-formed sleeves and films. Non-sterile. Single-use. Standards: ASTM F1670, F1671, D1004, D882, F1342; ISO 10993-5, 10993-10.

Indications for Use

Indicated for use as a barrier to cover dental instruments, including handpieces, curing lights, air/water syringes, dental chairs, instrument trays, x-ray heads, and digital sensors, for single patient use in a dental clinical setting.

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)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 14, 2019

UNiPACK Medical Corporation Joe Pomparelli Vice President 9830 Norwalk Blvd., Suite 100 Santa Fe Springs, California 90670

Re: K183263

Trade/Device Name: UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: Class II Product Code: PEM Dated: May 14, 2019 Received: May 20, 2019

Dear Joe Pomparelli:

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

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Elizabeth F. Claverie-Williams, MS Assistant Director. THT4B2: Disinfection Reprocessing and Personal Protection Acting Assistant Director, THT4B1: Sterility Devices 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020

510(k) Number (if known) K183263

Device Name UNiPACK Barrier Sleeve and Barrier Film and UNiGlide Barrier Envelope

Indications for Use (Describe)

UNiPACK Barrier Sleeve and Barrier Film and UNiGlide Barrier Envelope are intended to be used as a barrier to cover dental instruments. This device is non-sterile and intended for single patient use only.

| Item # | Description | Designed For |
|-------------|-------------------------------------------------------------|-----------------------------------------------------------------|
| UBC-8010E | E Tray Sleeve, 11-1/2" x 16" | Instrument trays |
| UBC-8011A | A Tray Sleeve, 11-5/8" x 14-1/2" | Instrument trays |
| UBC-8012B | B Tray Sleeve, 10-1/2" x 14" | Instrument trays |
| UBC-8013F | F Tray Sleeve, 7-1/2" x 10-1/2" | Instrument trays |
| UBC-8021 | Full Chair Cover, 29" x 80" | Chairs/Stools |
| UBC-8022 | Full Chair Cover, 48" x 56" | Chairs/Stools |
| UBC-8023 | Half Chair Cover, 27-1/2" x 24" | Chair Headrest |
| UBC-8024 | Headrest Cover, 11" x 9-1/2" x 2" | Chair Headrest |
| UBC-8025 | Headrest Cover, 14" x 9-1/2" x 2" | Chair Headrest |
| UBC-8028 | Syringe Sleeve with Opening, Clear, 2-1/2"x 10" | 3-way syringes, saliva ejectors and<br>HVE valves |
| UBC-8029 | Syringe Sleeve with Opening, Blue, 2-1/2"x 10" | 3-way syringes, saliva ejectors and<br>HVE valves |
| UBC-8031 | T-Handle Cover (T Shape), 4" x 5-3/4" | Most T-style dental chair light<br>handles |
| UBC-8032 | Universal X-Ray Cover, 23" x 31" | X-Ray head, Extra-Long |
| UBC-8033 | Universal X-Ray Cover, 15" x 26" | X-Ray head, Regular |
| UBC-8034 | Curing Light, Pistol (Handle Only) | Curing Lights, Pen Type |
| UBC-80341-F | Curing Light, Pistol (Full Cover with Vented<br>Design) | Curing Lights, Pen Type |
| UBC-80342-S | Curing Light, Pen Type (Small), 2" x 12-1/2" | Curing Lights, Pen Type |
| UBC-80343-L | Curing Light, Pen (Large), 3-1/8" x 12-1/2" | Curing Lights, Pen Type |
| UBC-8035 | Low Speed Pen Sleeve, 1-1/2" x 9" | Curing Lights, Pen Type |
| UBC-8036 | High Speed Universal, 1" x 9" | Curing Lights, Pen Type |
| UBC-8035 | Low Speed Pen Sleeve, 1-1/2" x 9" | Curing Lights, Pen Type |
| UBC-8036 | High Speed Universal, 1" x 9" | Curing Lights, Pen Type |
| UBC-8037 | Sensor Sleeve, Size 0 - Small | Digital X-Ray sensor, universal,<br>small, 1-3/8"x8" |
| Item # | Description | Designed For |
| UBC-8038 | Sensor Sleeve, Size 2 - Large | Digital X-Ray sensor, universal, large, 1 5/8"X8" |
| UBC-80392 | Tube Sleeve, 2" x 1200', cut to length | Dental unit tubing (2") |
| UBC-80394 | Tube Sleeve, 4" x 1200', cut to length | Dental unit tubing (4") |
| UBC-820824 | X-Ray Sensor Sheath (Schick, Size 1) | Digital X-Ray sensor (Schick/Dr. Suni<br>Plus) |
| UBC-820825 | X-Ray Sensor Sheath (Schick, Size 2) | Digital X-Ray sensor (Schick/Dr. Suni<br>Plus) |
| UBC-820861 | X-Ray Sensor Sheath (Regam, Size 2) | Digital X-Ray sensor (Regam) |
| UBC-820978 | X-Ray Sensor Sheath (Carestream/Kodak<br>6100, Size 1) | Digital X Ray sensor (Kodak 6100) |
| UBC-820979 | X-Ray Sensor Sheath (Carestream/Kodak<br>6100, Size 2) | Digital X Ray sensor (Kodak 6100) |
| UBC-820999 | X-Ray Sensor Sheath (Dexis/Universal) | Digital X Ray sensor (Dexis) |
| UBC-820831 | Intraoral Camera Covers | Pro-Den Systems/Dent-X, Pro-scope<br>1000 & Oral Scan, Easy Doc |
| UBC-820855 | Intraoral Camera Covers | Siemens, Ceracam/Minicam Ultra |
| UBC-820963 | Intraoral Camera Covers | Video Dental concepts, Quickcam<br>Smile |
| UBC-821013 | Intraoral Camera Covers | Digital Doc, Iris |
| UBE-8160 | UNIGLIDE PSP Barrier Envelope Size O | Phosphor Plate Covers |
| UBE-8161 | UNIGLIDE PSP Barrier Envelope Size 1 | Phosphor Plates Covers |
| UBE-8162 | UNIGLIDE PSP Barrier Envelope Size 2 | Phosphor Plates Covers |
| UBE-8050 | Standard PSP Barrier Envelope Size O | Phosphor Plates Covers |
| UBE-8051 | Standard PSP Barrier Envelope Size 1 | Phosphor Plates Covers |
| UBE-8052 | Standard PSP Barrier Envelope Size 2 | Phosphor Plates Covers |
| UBE-8053 | Standard PSP Barrier Envelope Size 3 | Phosphor Plates Covers |
| UBE-8054 | Standard PSP Barrier Envelope Size 4 | Phosphor Plates Covers |
| UBC-8040-U | Keyboard sleeves | Computer keyboard, universal,<br>22"X14" |
| UBC-8040-L | Keyboard sleeves | Computer keyboard, large, 19"X26" |
| UBC-8041 | LCD & Keyboard sleeves | Computer screen and keyboard,<br>universal |
| UBC-8042 | Laptop sleeves | Laptop, universal |
| UBC-8043-S | Low-speed contra-angle handpiece sleeves<br>w/paper backing | Dental low-speed contra-angle<br>handpiece, universal |
| UBC-8043-L | Low-speed long handpiece sleeves<br>w/paper backing | Dental low-speed long handpiece,<br>universal |
| UBC-8044 | Optical PC mouse barriers | Computer mouse, universal |
| UBC-8055 | Syringe sleeve w/paper backing | Air/water syringe, universal |
| UBC-8048 | Barrier film - Blue | Covers trays, accessories |
| UBC-8049 | Barrier Film - Clear | Covers trays, accessories |

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]Prescription Use (Part 21 CFR 801 Subpart D)

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Image /page/5/Picture/0 description: The image shows the logo for UniPACK Medical Corporation. The logo features the word "UniPACK" in a stylized font, with the "Uni" portion in blue and a red dot above the "i". Below the main logo, the words "UniPACK Medical Corporation" are written in a smaller, simpler font. The logo is clean and professional, suggesting a company in the medical field.

## 510(k) Summary for (K183263)

This is submitted in accordance with the requirements CFR 807.92.

## Applicant Information:

| Owner Name: | UNIPACK Medical Corporation | |
|-----------------|------------------------------------------------------------|--|
| Address: | 9830 Norwalk Blvd., Ste. 100<br>Santa Fe Springs, CA 90670 | |
| Contact Person: | Joe Pomparelli | |
| Phone Number: | [phone] | |
| Email: | [e-mail] | |
| Date Prepared: | June 13, 2019 | |

### Device Information:

| Trade Name: | UNIPACK Barrier Sleeve and Barrier Film and UNIGLIDE Barrier<br>Envelope |
|----------------------|--------------------------------------------------------------------------|
| Common name: | Dental Barriers and Sleeves |
| Classification name: | Surgical Drape and Drape Accessories |
| Regulation: | 21 CFR 878.4370 |
| Classification: | Class II |
| Product Code: | PEM, Dental Barriers and Sleeves |

## Legally Marketed Predicate Device:

| Company: | Pac-Dent International Inc. |
|---------------|-------------------------------------------------|
| Device: | Pac-Dent Barrier Sleeve, Cover-It™ Barrier Film |
| 510(k): | K151123 |
| Date Cleared: | March 3, 2016 |

#### Device Description: 1.1

The UNIPACK Barrier Sleeve and Barrier Film consist of various sizes and shapes of polyethylene covers which are positioned on various small hand-held dental instruments such as handpieces, curing lights, air/water syringes, and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, etc. The devices are sold non-sterile, prepackaged, and are for single use only.

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# 1.2 Indication for Use:

The UNiPACK Barrier Sleeve and Barrier Film are intended to be used as a barrier to cover dental instruments. This device is non-sterile and intended for single patient use only.

| Item # | Description | Designed For |
|-------------|-------------------------------------------------------------|---------------------------------------------------------------------|
| UBC-8010E | E Tray Sleeve, 11-1/2" x 16" | Instrument trays |
| UBC-8011A | A Tray Sleeve, 11-5/8" x 14-1/2" | Instrument trays |
| UBC-8012B | B Tray Sleeve, 10-1/2" x 14" | Instrument trays |
| UBC-8013F | F Tray Sleeve, 7-1/2" x 10-1/2" | Instrument trays |
| UBC-8021 | Full Chair Cover, 29" x 80" | Chairs/Stools |
| UBC-8022 | Full Chair Cover, 48" x 56" | Chairs/Stools |
| UBC-8023 | Half Chair Cover, 27-1/2" x 24" | Chair Headrest |
| UBC-8024 | Headrest Cover, 11" x 9-1/2" x 2" | Chair Headrest |
| UBC-8025 | Headrest Cover, 14" x 9-1/2" x 2" | Chair Headrest |
| UBC-8028 | Syringe Sleeve with Opening, Clear, 2-1/2"x 10" | 3-way syringes, saliva ejectors<br>and HVE valves |
| UBC-8029 | Syringe Sleeve with Opening, Blue, 2-1/2"x 10" | 3-way syringes, saliva ejectors<br>and HVE valves |
| UBC-8031 | T-Handle Cover (T Shape), 4" x 5-3/4" | Most T-style dental chair light<br>handles |
| UBC-8032 | Universal X-Ray Cover, 23" x 31" | X-Ray head, Extra-Long |
| UBC-8033 | Universal X-Ray Cover, 15" x 26" | X-Ray head, Regular |
| UBC-8034 | Curing Light, Pistol (Handle Only) | Curing Lights, Pen Type |
| UBC-80341-F | Curing Light, Pistol (Full Cover with Vented<br>Design) | Curing Lights, Pen Type |
| UBC-80342-S | Curing Light, Pen Type (Small), 2" x 12-1/2" | Curing Lights, Pen Type |
| UBC-80343-L | Curing Light, Pen (Large), 3-1/8" x 12-1/2" | Curing Lights, Pen Type |
| UBC-8035 | Low Speed Pen Sleeve, 1-1/2" x 9" | Curing Lights, Pen Type |
| UBC-8036 | High Speed Universal, 1" x 9" | Curing Lights, Pen Type |
| UBC-8035 | Low Speed Pen Sleeve, 1-1/2" x 9" | Curing Lights, Pen Type |
| UBC-8036 | High Speed Universal, 1" x 9" | Curing Lights, Pen Type |
| UBC-8037 | Sensor Sleeve, Size 0 - Small | Digital X-Ray sensor, universal,<br>small, 1 3/8"X8" |
| UBC-8038 | Sensor Sleeve, Size 2 - Large | Digital X-Ray sensor, universal,<br>large, 1 5/8"X8" |
| UBC-80392 | Tube Sleeve, 2" x 1200', cut to length | Dental unit tubing (2") |
| UBC-80394 | Tube Sleeve, 4" x 1200', cut to length | Dental unit tubing (4") |
| UBC-820824 | X-Ray Sensor Sheath (Schick, Size 1) | Digital X-Ray sensor<br>(Schick/Dr. Suni Plus) |
| UBC-820825 | X-Ray Sensor Sheath (Schick, Size 2) | Digital X-Ray sensor<br>(Schick/Dr. Suni Plus) |
| UBC-820861 | X-Ray Sensor Sheath (Regam, Size 2) | Digital X-Ray sensor (Regam) |
| UBC-820978 | X-Ray Sensor Sheath (Carestream/Kodak 6100,<br>Size 1) | Digital X Ray sensor (Kodak<br>6100) |
| Item # | Description | Designed For |
| UBC-820979 | X-Ray Sensor Sheath (Carestream/Kodak 6100,<br>Size 2) | Digital X Ray sensor (Kodak<br>6100) |
| UBC-820999 | X-Ray Sensor Sheath (Dexis/Universal) | Digital X Ray sensor (Dexis) |
| UBC-820831 | Intraoral Camera Covers | Pro-Den Systems/Dent-X, Pro-<br>scope 1000 & Oral Scan, Easy<br>Doc |
| UBC-820855 | Intraoral Camera Covers | Siemens, Ceracam/Minicam<br>Ultra |
| UBC-820963 | Intraoral Camera Covers | Video Dental concepts,<br>Quickcam Smile |
| UBC-821013 | Intraoral Camera Covers | Digital Doc, Iris |
| UBE-8160 | UNIGLIDE PSP Barrier Envelope Size 0 | Phosphor Plate Cover |
| UBE-8161 | UNIGLIDE PSP Barrier Envelope Size 1 | Phosphor Plate Cover |
| UBE-8162 | UNIGLIDE PSP Barrier Envelope Size 2 | Phosphor Plate Cover |
| UBE-8050 | Standard PSP Barrier Envelope Size 0 | Phosphor Plate Cover |
| UBE-8051 | Standard PSP Barrier Envelope Size 1 | Phosphor Plate Cover |
| UBE-8052 | Standard PSP Barrier Envelope Size 2 | Phosphor Plate Cover |
| UBE-8053 | Standard PSP Barrier Envelope Size 3 | Phosphor Plate Cover |
| UBE-8054 | Standard PSP Barrier Envelope Size 4 | Phosphor Plate Cover |
| UBC-8040-U | Keyboard sleeves | Computer keyboard,<br>universal, 22"X14" |
| UBC-8040-L | Keyboard sleeves | Computer keyboard, large,<br>19"X26" |
| UBC-8041 | LCD & Keyboard sleeves | Computer screen and<br>keyboard, universal |
| UBC-8042 | Laptop sleeves | Laptop, universal |
| UBC-8043-S | Low-speed contra-angle handpiece sleeves<br>w/paper backing | Dental low-speed contra-angle<br>handpiece, universal |
| UBC-8043-L | Low-speed long handpiece sleeves w/paper<br>backing | Dental low-speed long<br>handpiece, universal |
| UBC-8044 | Optical PC mouse barriers | Computer mouse, universal |
| UBC-8055 | Syringe sleeve w/paper backing | Air/water syringe, universal |
| UBC-8048 | Barrier Film - Blue | Cover trays, accessories |
| UBC-8049 | Barrier film - clear | Cover trays, accessories |

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### 1.3 Technical Characteristics:

| Descriptive Information | UNIPACK Barrier Sleeve,<br>Barrier Film and UniGlide<br>Barrier Envelope<br>(Subject Device) | Pac-Dent Barrier Sleeve<br>Cover-It™ Barrier Film<br>510(k) #K151123 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The UNIPACK Barrier Sleeve,<br>Barrier Film and UNIGLIDE<br>Barrier Envelopes are intended<br>to be used as a barrier to cover<br>dental instruments. This device<br>is non-sterile and intended for<br>single patient use only. | Pac-Dent Barrier Sleeve and<br>Cover-It Barrier Film are<br>intended to be used as a barrier<br>to cover dental instruments. This<br>device is non-sterile and<br>intended for single patient use<br>only. |
| Regulation Number | 21 CFR 878.4370 | 21 CFR 878.4370 |
| Classification Product Code | PEM | PEM |
| Product Classification | Class II | Class II |
| Composition of Materials | LLDPE (80%)<br>LDPE (20%) | LLDPE (80%)<br>LDPE (20%) |
| Sterility | Non-Sterile | Non-Sterile |
| Labeling | Single Use Only, OTC | Single Use Only, OTC |
| Specifications | Film Thickness: 0.02-0.06mm<br>Tolerance: 0.01mm<br>Paper Backing – some models | Film Thickness: 0.02-0.06mm<br>Tolerance: 0.01mm<br>Paper Backing - some models |
| | Film Thickness | Film Thickness |
| | Resistance to Penetration<br>- ASTM F1670: Pass<br>- ASTM F1671: Pass | Resistance to Penetration<br>- ASTM F1670: Pass<br>- ASTM F1671: Pass |
| | Tear Strength<br>- ASTM D1424: Pass | Tear Strength<br>- ASTM D1424: Pass |
| | Tensile Properties<br>- ASTM D882: Pass | Tensile Properties<br>- ASTM D882: Pass |
| Performance Testing | Resistance to Puncture<br>- ASTM F1342: Pass | Resistance to Puncture<br>- ASTM F1342: Pass |
| | Effectiveness of X-Ray Devices<br>Covered with Barrier Sleeves<br>determined to be same as<br>without Barrier Sleeves using<br>side-by-side visual comparison<br>of pictures of common dental<br>office objects. | Effectiveness of X-Ray Devices<br>Covered with Barrier Sleeves:<br>Pass |
| Biocompatibility | ISO 10933-5 (cytotoxicity): Pass<br>ISO 10933-10 (irritation): Pass<br>ISO 10933-10 (sensitization):<br>Pass | ISO 10933-5 (cytotoxicity): Pass<br>ISO 10933-10 (irritation): Pass<br>ISO 10933-10 (sensitization):<br>Pass |
| Descriptive Information | UNIPACK Barrier Sleeve,<br>Barrier Film and UniGlide<br>Barrier Envelope<br>(Subject Device) | Pac-Dent Barrier Sleeve<br>Cover-ItTM Barrier Film<br>510(k) #K151123 |
| FDA Recognized Standards | ASTM F1670 | ASTM F1670 |
| | ASTM D1004 | ASTM D1004 |
| | ASTM D882 | ASTM D882 |
| | ASTM F1342 | ASTM F1342 |
| | ASTM F1671 | ASTM F1671 |
| | ISO 10993-5 | ISO 10993-5 |
| | ISO 10993-10 | ISO 10993-10 |

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### Summary of Non-Clinical Tests 1.4

The following table summarizes the non-clinical performance testing.

| Test Item | Methodology | Purpose | Acceptance<br>Criteria | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM F1670:<br>Resistance of<br>Materials Used in<br>Protective Clothing<br>to Penetration by<br>Synthetic Blood | Study conducted per<br>ASTM F1670<br>Study Endpoint:<br>Observed for synthetic<br>blood penetration at<br>conclusion of study | Evaluate<br>resistance of<br>protective<br>materials to<br>penetration by<br>synthetic blood<br>under conditions of<br>continuous liquid<br>contact. | Acceptance criteria<br>per ASTM F1670<br>Pass/Fail based on<br>synthetic blood<br>penetration<br>observations.<br>Pass=no<br>penetration | Material used for<br>Unipack Dental<br>Barrier Film and<br>Sleeves could not<br>be penetrated by<br>synthetic blood<br>under study<br>conditions. The<br>material meets the<br>requirements of<br>ASTM F1670 in<br>preventing<br>synthetic blood<br>penetration. |
| ASTM F1671:<br>Resistance of<br>Materials used in<br>Protective Clothing<br>to Penetration by<br>Blood-Borne<br>Pathogens using<br>Phi-X174<br>Bacteriophage<br>Penetration as a<br>Test System<br>Penetration | Study conducted per<br>ASTM F1671 | Evaluate barrier<br>performance of<br>protective<br>materials which<br>are intended to<br>protect against<br>blood borne<br>pathogen hazards. | Acceptance criteria<br>per ASTM F1671 | Material used for<br>Unipack Dental<br>Barrier Film and<br>Sleeves met<br>criteria of test<br>standard under<br>study conditions.<br>The material<br>meets the<br>requirements of<br>ASTM F1671 in<br>preventing blood<br>borne pathogen<br>penetration. |
| ASTM D882:<br>Standards Test<br>Methods for Tensile<br>Properties of Thin<br>Plastic Sheeting | Study conducted per<br>ASTM D882<br>Study Endpoint:<br>To failure of test article | Determine tensile<br>strength. | Per ASTM D882,<br>there is currently<br>no acceptance<br>criteria for this test<br>method. | The results are for<br>information only as<br>there is no P/F<br>criteria. |

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| Test Item | Methodology | Purpose | Acceptance<br>Criteria | Results |
|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM F1342:<br>Standard Test<br>method for<br>protective Clothing<br>Material Resistance<br>to Puncture | Study conducted per<br>ASTM F1342<br>Study Endpoint:<br>At the point of material<br>puncture. | Determine<br>puncture<br>resistance of a<br>protective clothing<br>material. | Per ASTM F1342,<br>there is currently<br>no acceptance<br>criteria for this test<br>method. | The results are for<br>information only as<br>there is no P/F<br>criteria. |
| ASTM D1004:<br>Standard Test<br>Method for Tear<br>Resistance (Graves<br>Tear) of Plastic Film<br>and Sheeting | Study conducted per<br>ASTM D1004<br>Study Endpoint:<br>At the point of material<br>tearing. | Determine tear<br>strength of plastic<br>film and sheeting. | per ASTM D1004,<br>there is currently<br>no acceptance<br>criteria for this test<br>method. | The results are for<br>information only as<br>there is no P/F<br>criteria. |
| ISO 10993-5:<br>Biological evaluation of<br>medical devices - Part<br>5: Tests for in vitro<br>cytotoxicity | Study conducted in<br>compliance to ISO<br>10993-5: 2009 and BS<br>EN ISO 10993-5: 2009<br>(Tests for in vitro<br>Cytotoxicity). Test and/or<br>control article prepared<br>in compliance to ISO<br>10993-12: 2012 and BS<br>EN ISO 10993-12: 2012<br>(Sample Preparation<br>and Reference | Purpose of MEM<br>Elution Cytotoxicity<br>test was to<br>determine<br>cytotoxic response<br>from test article<br>which was<br>extracted in cell<br>culture media<br>which was then<br>plated onto L-929<br>mouse fibroblast | Acceptance criteria<br>per ISO 10993-5. | Test article passed<br>test and<br>determined non-<br>cytotoxic. |
| Test Item | Methodology | Purpose | Acceptance<br>Criteria | Results |
| ISO 10993-10:<br>Biological evaluation of<br>medical devices - Part<br>10: Tests for irritation<br>and skin sensitization | Studies (2) conducted in<br>compliance to<br>ISO)10993-10: 2010 and<br>BS EN ISO 10993-10:<br>2013 (Tests for Irritation<br>and Skin Sensitization).<br>Test or control article<br>prepared in compliance<br>to ISO 10993-12: 2012<br>and BS EN ISO 10993-<br>12: 2012 (Sample<br>Preparation and<br>Reference Materials). | Study 1 purpose:<br>To evaluate<br>sensitization or<br>allergenic potential<br>of a test article.<br>Test is used as<br>method for<br>screening contact<br>allergens in guinea<br>pigs. Results are<br>used as predictive<br>measures for<br>detecting potential<br>sensitizers in<br>humans.<br>Study 2 purpose:<br>To evaluate<br>irritation potential<br>of a test article.<br>Test is used as<br>method for<br>screening irritants<br>in rabbits. Results<br>are used as<br>predictive<br>measures for<br>detecting potential<br>irritants in humans. | Acceptance criteria<br>for both studies per<br>ISO 10993-10. | Study completed<br>and test article<br>considered non-<br>sensitizer.<br>Study completed<br>and test article<br>considered non-<br>irritant. |
| X-Ray<br>Effectiveness:<br>Currently no<br>standard is<br>available. | Side-by-side visual<br>comparison of X-Ray<br>pictures of common<br>dental office objects. | Determine<br>effectiveness of X-<br>Ray devices<br>covered with<br>Barrier Sleeves. | Expert X-Ray<br>reader should not<br>be able to observe<br>differences<br>between images of<br>same objects<br>captured with and<br>w/o Barrier Sleeves<br>covering X-Ray<br>source. | Images were<br>deemed to be the<br>same by a trained<br>X-Ray reader. |

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### Clinical Performance Test 1.5

No clinical testing was performed.

### 1.6 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Pac-Dent Barrier Sleeve and Cover-It Barrier Film (K151123).