Premium Plus Disposable Barrier Sleeve

K163447 · Premium Plus International Limited · PEM · Jun 20, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K163447
• Device Name: Premium Plus Disposable Barrier Sleeve
• Applicant: Premium Plus International Limited
• Product Code: PEM · General, Plastic Surgery
• Decision Date: Jun 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Indications for Use

Premium Plus Disposable Barrier Sleeve is 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.

Device Story

Premium Plus Disposable Barrier Sleeves are polyethylene film covers designed for dental instruments and equipment; including handpieces, curing lights, air/water syringes, trays, x-ray heads, and dental chairs. Used in dental clinics by dental professionals to provide a physical barrier against contamination during procedures. The sleeves are non-sterile, single-use, and disposable. By covering equipment, they prevent cross-contamination between patients and protect the equipment surface. Healthcare providers apply the sleeves manually before procedures and dispose of them afterward. The device does not alter the function of the covered equipment.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing, including resistance to penetration (ASTM F1670, F1671), mechanical properties (ASTM D882, F1342, D1004), and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Materials: Low density polyethylene and linear low density polyethylene film. Thickness: 0.03mm. Form factor: Various sizes/shapes for dental equipment. Sterilization: Non-sterile. Standards: ASTM F1670, ASTM F1671, ASTM D882, ASTM F1342, ASTM D1004, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for use as a disposable barrier for dental instruments and equipment in a dental setting. Intended for single patient 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 (K151123)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 20, 2017

Premium Plus International Limited Jessica Mao OA Engineer Flat 1001 Yuen Long Trading Centre, 33 Wang Yip Street West Yuen Long N.t. Hong Kong, CN

Re: K163447

Trade/Device Name: Premium Plus Disposable Barrier Sleeve Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape And Drape Accessories Regulatory Class: Class II Product Code: PEM Dated: November 30, 2016 Received: December 8, 2016

Dear Jessica Mao:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Lori A. Wiggins -S6

Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known) K163447

Device Name

Premium Plus Disposable Barrier Sleeve

Indications for Use (Describe)

Premium Plus Disposable Barrier Sleeve is 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.

Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Flat 1001 Yven Long Trading Centre, No. 33 Wang Yip Street West, Yven Long, HONG KONG Phone: [phone], Facsimile: (852) 2761 3210, Email: [e-mail]

### Section 5 510(k) Summary [As Required by 21 CFR 807.92]

510(k) Number: K163447

Premium Plus International Limited Submitter: Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, N.T. Hong Kong, China (Establishment registration number: 3006847937)

Contact Person: Jessica Mao QA Engineer Tel: [phone] Fax: [phone] Email: [e-mail]

Trade Name: Premium Plus Disposable Barrier Sleeve Common Name: Dental Barriers and Sleeves Device Panel: General and Plastic Surgery Basis for Submission: New Device Regulation Name: Surgical Drape and Drape Accessories Device Classification: Class II Regulation Number: 21 CFR 878.4370 Product Code: PEM

#### Predicate Device to Premium Plus Disposable Barrier Sleeves:

Trade Name: Pac-Dent Barrier Sleeve 510(k) Number: K151123 Manufactured by: Pac-Dent International, Inc.

#### Device Description:

Premium Plus Disposable Barrier Sleeves are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These barrier sleeves consist of various sizes and shapes 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 travs, x-ray heads, and others. The products are sold nonsterile, prepackaged, and are disposable, single use only.

#### Indications for Use:

Premium Plus Disposable Barrier Sleeves 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.

Page 1 of 7

{4}------------------------------------------------

Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG
Phone: [phone], Facsimile: (852) 2761 3210, Email: [e-mail]

### Device Models:

| Model# | Description | Designed for |
|--------|-----------------------------------------------------|-------------------------------------------------------------|
| 100A | Syringe Sleeves with Adhesive<br>Tape, 500 pcs/box | 3-way syringes, saliva ejectors and HVE valve |
| 100B | Syringe Sleeves Blue, 500<br>pcs/box | 3-way syringes, saliva ejectors and HVE valve |
| 100C | Syringe Sleeves Clear, 500<br>pcs/box | 3-way syringes, saliva ejectors and HVE valve |
| 101 | Tray Sleeves Standard 'B', 500<br>pcs/box | Instrument trays |
| 102 | Tray Sleeves Mini 'F', 500<br>pcs/box | Instrument trays |
| 103 | High Speed / Pen Sleeves, 500<br>pcs/box | Most handpieces, jet polishers and ultrasonic<br>scalers |
| 104 | Low Speed / Universal Sleeves,<br>500 pcs/box | Most handpieces, jet polishers and<br>ultrasonic<br>scalers |
| 105 | Curing Light Handle Sleeves, 500<br>pcs/box | Curing light, pistol type |
| 106 | T Light Handle Sleeves, U-shape,<br>500 pcs/box | Most T-style dental chair light handles |
| 107 | Impression Gun Sleeves, 500<br>pcs/box | Impression guns |
| 108 | X-Ray Head / Keyboard Sleeves,<br>250 pcs/box | X-ray head/keyboard |
| 109 | X-Ray Head Sleeves Large, 250<br>pcs/box | X-ray head |
| 111 | Full Chair Sleeves, 125 pcs/box | Dental chairs |
| 112 | Half Chair / Stool Sleeves, 125<br>pcs/box | Dental chairs/stools |
| 113 | Headrest Sleeves Small, 500<br>pcs/box | Dental chair headrest |
| 114 | Headrest Sleeves Large, 500<br>pcs/box | Dental chair headrest |
| 118 | Straight Tubing Sleeves, 366<br>meters | Dental chair tubing |
| 119 | Coiled Tubing Sleeves, 366<br>meters | Dental chair tubing |
| 123L | Curing Light Sleeves Pen Type<br>Large, 500 pcs/box | Curing lights, pen type |
| 123S | Curing Light Sleeves Pen Type<br>Small, 500 pcs/box | Curing lights, pen type |
| 123SS | Curing Light Sleeves Pen Type<br>Small, 500 pcs/box | Curing lights, pen type |

{5}------------------------------------------------

Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG

| | | | Phone: [phone], Facsimile: (852) 2761 3210, Email: [e-mail] | |
|--|--|--|-----------------------------------------------------------------------------------------|--|

| | | Phone: [phone], Facsimile: (852) 2761 3210, Email: [e-mail] |
|--------|----------------------------------------------------|-----------------------------------------------------------------------------------------|
| 125 | Intraoral Camera Sleeves, 500 pcs/box | Intraoral Cameras |
| 125SS | Intraoral Camera/Curing Light Sleeves, 500 pcs/box | Intraoral Cameras/curing lights |
| 128 | Light Guide Sleeves, Small, 200 pcs/box | Curing light guides |
| 129 | Light Guide Sleeves, Large, 200 pcs/box | Curing light guides |
| 133 | PC Mouse Sleeves, 500 pcs/box | PC mouses |
| 135 | HVE Suction Tube Sleeves, 500 pcs/box | HVE suction tubes |
| 136 | T Light Handle Sleeves, Rectangular, 500 pcs/box | T-style dental chair light handles |
| 138 | Flowable Composite Syringe Sleeves, 200 pcs/box | Composite syringes |
| 140L | X-Ray Sensor Sleeves, Large, 500 pcs/box | X-ray sensors |
| 140M | X-Ray Sensor Sleeves, Medium, 500 pcs/box | X-ray sensors |
| 140S | X-Ray Sensor Sleeves, Small, 500 pcs/box | X-ray sensors |
| 140XS | X-Ray Sensor/Mouth Mirror Sleeves, 500 pcs/box | X-ray sensors/mouth mirrors |
| 145 | Bite Block Sleeves, 1000 pcs/box | Bite Block |
| 155 | Tablet Sleeves, 500pcs/box | Tablet/Pad |
| 158 | Keyboard Sleeves, 500 pcs/box | Keyboards |
| 183-1 | X-Ray Sensor Sleeves Two Step, Size 1, 500 | X-ray sensors |
| 183-2 | X-Ray Sensor Sleeves Two Step, Size 2, 500 | X-ray sensors |
| 190 | ISO Tray Sleeves, 500 pcs/box | Instrument Trays |
| 105T | Curing Light Sleeves Complete, 500 pcs/box | Curing lights |
| 121 | Lab Transport Bags, 100 pcs/box | Transport of dental materials |
| 188-0 | PSP X-Ray Barrier Envelopes, No. 0, 100 pcs/box | Phosphor Plates |
| 188-1 | PSP X-Ray Barrier Envelopes, No. 1, 100 pcs/box | Phosphor Plates |
| 188-2 | PSP X-Ray Barrier Envelopes, No. 2, 100 pcs/box | Phosphor Plates |
| 188-2B | PSP X-Ray Barrier Envelopes, No. 2, 500 pcs/box | Phosphor Plates |
| 188-3 | PSP X-Ray Barrier Envelopes, No. 3, 50 pcs/box | Phosphor Plates |

{6}------------------------------------------------

Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG

| Phone: [phone], Facsimile: (852) 2761 3210, Email: [e-mail] | | | | |
|-----------------------------------------------------------------------------------------|--|--|--|--|
| | | | | |

| 189-0<br>No. 0, 100 pcs/box | PSP X-Ray Barrier Envelopes, | Phosphor Plates |
|------------------------------|-----------------------------------|--------------------------------------------------------|
| 189-1<br>No. 1, 100 pcs/box | PSP X-Ray Barrier Envelopes, | Phosphor Plates |
| 189-2<br>No. 2, 100 pcs/box | PSP X-Ray Barrier Envelopes, | Phosphor Plates |
| 198-0<br>No. 0, 100 pcs/box | PSP X-Ray Barrier Envelopes, | Phosphor Plates |
| 198-2<br>No. 2, 100 pcs/box | PSP X-Ray Barrier Envelopes, | Phosphor Plates |
| 198-2B<br>No. 2, 500 pcs/box | PSP X-Ray Barrier Envelopes, | Phosphor Plates |
| 199-0<br>No. 0, 100 pcs/box | PSP X-Ray Barrier Envelopes, | Phosphor Plates |
| 199-1<br>No. 1, 100 pcs/box | PSP X-Ray Barrier Envelopes, | Phosphor Plates |
| 199-2<br>No. 2, 100 pcs/box | PSP X-Ray Barrier Envelopes, | Phosphor Plates |
| 8008-B<br>sheets/roll | Barrier Film 4" x 6", Clear, 1200 | Surface area that might be touched<br>during procedure |
| 8008-C<br>sheets/roll | Barrier Film 4" x 6", Blue, 1200 | Surface area that might be touched<br>during procedure |

### Overall Dimensions (by Inches):

| Model# | Device Description | Size |
|--------|-------------------------------------------------|---------------------|
| 100A | Syringe Sleeves with Adhesive Tape, 500 pcs/box | 10 15/64"x2 9/16" |
| 100B | Syringe Sleeves Blue, 500 pcs/box | 10 15/64"x2 9/16" |
| 100C | Syringe Sleeves Clear, 500 pcs/box | 10 15/64"x2 9/16" |
| 101 | Tray Sleeves Standard 'B', 500 pcs/box | 14 11/64"x10 5/8" |
| 102 | Tray Sleeves Mini 'F', 500 pcs/box | 11 1/32"x7 31/64" |
| 103 | High Speed / Pen Sleeves, 500 pcs/box | 8 21/32"x15/16" |
| 104 | Low Speed / Universal Sleeves, 500 | 8 21/32"x1 1/2" |
| 105 | Curing Light Handle Sleeves, 500 pcs/box | 10 19/32"x5 19/32" |
| 106 | T Light Handle Sleeves, U-shape, 500 pcs/box | 5 29/32"x3 11/32" |
| 107 | Impression Gun Sleeves, 500 pcs/box | 8 17/64"x9 27/32" |
| 108 | X-Ray Head / Keyboard Sleeves, 250 pcs/box | 23 5/8"x7 7/8" |
| 109 | X-Ray Head Sleeves Large, 250 pcs/box | 29 17/32"x13 25/32" |
| 111 | Full Chair Sleeves, 125 pcs/box | 70 55/64"x28 11/32" |
| 112 | Half Chair / Stool Sleeves, 125 pcs/box | 39 3/8"x25 19/32" |
| 113 | Headrest Sleeves Small, 500 pcs/box | 10 15/64"x10 53/64" |
| 114 | Headrest Sleeves Large, 500 pcs/box | 11 1/32"x13 25/32" |
| 118 | Straight Tubing Sleeves, 366 meters | 11 13/16"x1 31/32" |
| 119 | Coiled Tubing Sleeves, 366 meters | 11 13/16"x3 15/16" |

{7}------------------------------------------------

Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG

| | rang rade reduced reduction and trainer respendent reduction comment coment coment coment ordered. |
|--|----------------------------------------------------------------------------------------------------|
| | Phone: [phone], Facsimile: (852) 2761 3210, Email: [e-mail] |

| 123L | Curing Light Sleeves Pen Type Large, 500<br>pcs/box | 13 25/32"x2 9/16" |
|--------|-------------------------------------------------------|--------------------|
| 123S | Curing Light Sleeves Pen Type Small, 500<br>pcs/box | 12 19/32"x1 31/32" |
| 123SS | Curing Light Sleeves Pen Type X-Small, 500<br>pcs/box | 11 1/32"x1 31/32" |
| 125 | Intraoral Camera Sleeves, 500 pcs/box | 12 19/32"x1 57/64" |
| 125SS | Intraoral Camera/Curing Light Sleeves, 500<br>pcs/box | 11 1/32"x1 57/64" |
| 128 | Light Guide Sleeves, Small, 200 pcs/box | 3 15/32"x3 11/32" |
| 129 | Light Guide Sleeves, Large, 200 pcs/box | 3 15/16"x3 35/64" |
| 133 | PC Mouse Sleeves, 500 pcs/box | 5 29/32"x3 11/32" |
| 135 | HVE Suction Tube Sleeves, 500 pcs/box | 2 11/64"x13 25/32" |
| 136 | T Light Handle Sleeves, Rectangular, 500 pcs/box | 5 29/32"x3 15/16" |
| 138 | Flowable Composite Syringe Sleeves, 200 pcs/box | 4 59/64"x1 31/32" |
| 140L | X-Ray Sensor Sleeves, Large, 500 pcs/box | 9 27/32"x2 23/64" |
| 140M | X-Ray Sensor Sleeves, Medium, 500 pcs/box | 7 7/8"x1 49/64" |
| 140S | X-Ray Sensor Sleeves, Small, 500 pcs/box | 7 7/8"x1 21/32" |
| 140XS | X-Ray Sensor/Mouth Mirror Sleeves, 500 pcs/box | 7 7/8"x1 1/2" |
| 145 | Bite Block Sleeves, 1000 pcs/box | 2 11/64"x1 1/32" |
| 155 | Tablet Sleeves, 500pcs/box | 7 7/8"x11 39/64" |
| 158 | Keyboard Sleeves, 500 pcs/box | 6 19/64"x21 21/32" |
| 183-1 | X-Ray Sensor Sleeves Two Step, Size 1, 500 | 8 21/32"x1 31/32" |
| 183-2 | X-Ray Sensor Sleeves Two Step, Size 2, 500 | 8 21/32"x2 11/64" |
| 190 | ISO Tray Sleeves, 500 pcs/box | 12 3/16"x8 1/4" |
| 105T | Curing Light Sleeves Complete, 500 pcs/box | 10 19/32"x5 19/32" |
| 121 | Lab Transport Bags, 100 pcs/box | 8 21/32"x7 3/32" |
| 188-0 | PSP X-Ray Barrier Envelopes, No. 0, 100 pcs/box | 1 27/64"x1 49/64" |
| 188-1 | PSP X-Ray Barrier Envelopes, No. 1, 100 pcs/box | 1 31/32"x1 29/64" |
| 188-2 | PSP X-Ray Barrier Envelopes, No. 2, 100 pcs/box | 2 1/64"x1 11/16" |
| 188-2B | PSP X-Ray Barrier Envelopes, No. 2, 500 pcs/box | 2 1/64"x1 11/16" |
| 188-3 | PSP X-Ray Barrier Envelopes, No. 3, 50 pcs/box | 2 33/64"x1 1/2" |
| 188-4 | PSP X-Ray Barrier Envelopes, No. 4, 50 pcs/box | 3 15/32"x2 43/64" |
| 189-0 | PSP X-Ray Barrier Envelopes, No. 0, 100 pcs/box | 1 1/2"x1 3/8" |
| 189-1 | PSP X-Ray Barrier Envelopes, No. 1, 100 pcs/box | 1 3/16"x2 3/32" |
| 189-2 | PSP X-Ray Barrier Envelopes, No. 2, 100 pcs/box | 2 3/32"x1 29/64" |
| 198-0 | PSP X-Ray Barrier Envelopes, No. 0, 100 pcs/box | 1 57/64"x1 7/32" |
| 198-2 | PSP X-Ray Barrier Envelopes, No. 2, 100 pcs/box | 2 1/8"x1 1/2" |
| 198-2B | PSP X-Ray Barrier Envelopes, No. 2, 500 pcs/box | 2 1/8"x1 1/2" |
| 199-0 | PSP X-Ray Barrier Envelopes, No. 0, 100 pcs/box | 1 47/64"x1 3/8" |
| 199-1 | PSP X-Ray Barrier Envelopes, No. 1, 100 pcs/box | 2 3/64"x1 29/64" |
| 199-2 | PSP X-Ray Barrier Envelopes, No. 2, 100 pcs/box | 2 1/8"x1 47/64" |

{8}------------------------------------------------

Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG
Phone: [phone], Facsimile: (852) 2761 3210, Email: [e-mail]

| 8008-B | Barrier Film 4" x 6", Clear, 1200 sheets/roll | 4"x6" |
|--------|-----------------------------------------------|-------|
| 8008-C | Barrier Film 4" x 6", Blue, 1200 sheets/roll | 4"x6" |

#### Comparison of Technological Characteristics and Performance:

| Comparison of Technological Characteristics and Performance: | | |
|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Pac-Dent Barrier Sleeve<br>510(K) Number: K151123 | Premium Plus Disposable<br>Barrier Sleeves |
| Intended Use | To be used as a barrier to cover<br>dental instruments | To be used as a barrier for<br>dental instruments and<br>equipment |
| Classification<br>Product Code | PEM | PEM |
| Material | Polyethylene film | Polyethylene film |
| Material Composition | Low density polyethylene and<br>linear low density polyethylene<br>film | Low density polyethylene and<br>linear low density polyethylene<br>film |
| Biocompatibility | Non-cytotoxic<br>Non-sensitizing<br>Non-irritating | Non-cytotoxic<br>Non-sensitizing<br>Non-irritating |
| Film Thickness | 0.02mm- 0.06mm | 0.03mm |
| Mechanical<br>Properties(Pac-Dent<br>101 B Tray Sleeve<br>was tested for<br>comparison with the<br>proposed device) | Tensile Strength – tested in<br>compliance with ASTM D882<br><br>Puncture Resistance - tested in<br>compliance with ASTM F1342<br><br>Tear Resistance - tested in<br>compliance with ASTM D1424 | Mechanical properties of the<br>subject device are comparable<br>to the predicate device.<br>Tensile Strength, puncture<br>resistance and tear resistance<br>are equivalent to the predicate<br>device. |
| Sterility | Non-sterile | Non-sterile |
| Single Use | Single use device | Single use device |
| Performance<br>Properties | Synthetic Blood Penetration-<br>Pass<br>Viral Penetration-Pass | Synthetic Blood Penetration-<br>Pass<br>Viral Penetration-Pass |
| Dimensions | Determined by the size and<br>shape of dental instruments and<br>equipment | Difference in dimensions is due<br>to the size of instruments and<br>equipment they cover |
| FDA- Recognized<br>Standards | ASTM F1670<br>ASTM F1671<br>ASTM D882<br>ASTM F1342<br>ASTM D1004<br>ISO 10993-5<br>ISO 10993-10 | ASTM F1670<br>ASTM F1671<br>ASTM D882<br>ASTM F1342<br>ASTM D1004<br>ISO 10993-5<br>ISO 10993-10 |

{9}------------------------------------------------

Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG Phone: [phone], Facsimile: (852) 2761 3210, Email: [e-mail]

### Tests:

Performance test including resistance to penetration, tear strength, tensile properties, resistance to puncture was performed. Biocompatibility test in accordance with ISO 10993-5, ISO 10993-10 has been performed. Effectiveness of x-ray devices covered with Premium Plus Disposable Barrier Sleeves was performed to demonstrate the subject device does not impact the function of dental x-ray devices.

The biocompatibility test result indicates that the disposable barrier sleeves do not have the potential cytotoxicity, hypersensitivity and irritation.

### Clinical Performance Data:

No data from human clinical studies have been included to support the substantial equivalence of the proposed devices, Premium Plus International Limited, as clinical studies is not required for this medical device.

#### Conclusion

Based on the tests performed the subject device Premium Plus Disposable Barrier Sleeve is as safe and as effective, and performs as well as the legally marketed predicate device.