(195 days)
Not Found
No
The device description and performance studies focus on physical properties and barrier function, with no mention of AI or ML.
No.
The device is described as a disposable barrier for dental instruments and equipment, and its intended use is to cover surfaces to prevent contamination. It does not perform any therapeutic function.
No.
The device is described as a disposable barrier for dental instruments and equipment, designed to cover instruments and devices like dental chairs and X-ray heads. Its intended use is to prevent contamination, not to diagnose medical conditions.
No
The device is described as physical barrier sleeves and film made of polyethylene, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable barrier for dental instruments and equipment." This is a physical barrier to prevent contamination, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details physical covers made of polyethylene. There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic tests.
- Performance Studies: The performance studies focus on physical properties like resistance to penetration, tear resistance, tensile strength, and puncture resistance, as well as biocompatibility. These are relevant for a physical barrier device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the BH Medical Dental Barrier Sleeves and Barrier Film are classified as a general medical device used for infection control in a dental setting, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BH Medical Dental 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.
Product codes (comma separated list FDA assigned to the subject device)
PEM
Device Description
BH Medical Dental Barrier Sleeves and Barrier Film consist of various sizes and shapes of clear polyethylene covers which are positioned on various small hand-held dental instruments such as hand pieces, 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, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance test including resistance to penetration, tear resistance, tensile strength, puncture resistance was performed. Biocompatibility test in accordance with ISO 10993-5, ISO 10993-10 has been performed. Effectiveness of x-ray devices covered with BH Dental 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 barrier sleeves do not have the potential cytotoxicity, sensitization and irritation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 878.4370 Surgical drape and drape accessories.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
September 10, 2019
BH Medical Products Co., Ltd. Xiaohua Tao President No.90 Shenjiang Villagers' group, Zhangjiacunwei, Xilin Street, Zhonglou District Changzhou. 213024 Cn
Re: K190484
Trade/Device Name: BH Medical Dental 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: August 6, 2019 Received: August 12, 2019
Dear Xiaohua Tao:
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.
1
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 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.
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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
2
Indications for Use
510(k) Number (if known) K190484
Device Name
BH Medical Dental Barrier Sleeves and Barrier Film
Indications for Use (Describe)
BH Medical Dental 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.
| Item # | Model | Designed for |
|---|---|---|
| #992514 | B tray sleeves | Dental instrument tray, 10 1/2"x14"(360x270mm) |
| #992515 | E tray sleeves | Dental instrument tray, 11 1/2"x16"(410x290mm) |
| #992516 | A tray sleeves | Dental instrument tray, 7 1/2"x10 1/2"(270x190mm) |
| #992446 | Headrest Cover | Dental chair headrest, 11"x9 1/2"(250x280mm) |
| #992447 | Headrest Cover | Dental chair headrest, 14"x9 1/2"(250x360mm) |
| #992513 | X-ray head sleeves | X-ray head, universal, 15"x26"(660x380mm) |
| #992481 | Full chair sleeves | Dental chair, universal, 29"x80"(2020x730mm) |
| #992479 | Half chair sleeves | Half dental chair, universal, 27 1/2"x24"(680x600mm) |
| #992486 | Syringe/HVE sleeve without tape | Air/water syringe HVE universal, 2 1/2"x10"(250x60x22mm) |
| #991372 | Digital x-ray sensor sleeve | Digital x-ray sensor, universal, large, 1 5/8"x8"(210x43mm) |
| #991371 | Digital x-ray sensor sleeve | Digital x-ray sensor, universal, large, 1 3/8"x8"(210x36mm) |
| #992492 | handpiece and pen sleeves-High speed | Dental high-speed handpiece universal(200x28mm) |
| #992493 | handpiece and pen sleeves-Lower speed | Dental low-speed handpiece universal(200x38mm) |
| #992499 | light handle sleeves | light handles, universal, T-shape(154x73mm) |
| #992508 | light handle sleeves | light handles, universal, Rectanglar(150x105mm) |
| #992495 | light cure sleeves | Dental curing light, medium,20mm |
| #992496 | light cure sleeves | Dental curing light, large,25mm |
| #992497 | light cure sleeves, curved tip | Dental curing light, medium,(340x53x16mm) |
| #992498 | light cure sleeves, curved tip | Dental curing light, large,(340x84x16mm) |
| #992582 | light cure sleeves, pen style | Dental curing light, pen type,tip:40x27mm,total:250x50mm |
| #992583 | light cure sleeves, pen style | Dental curing light, pen type,,tip:55x26mm,total:250x52mm |
| #992584 | light cure sleeves, pen style | Dental curing light, pen type,tip:40x30mm,total:250x55mm |
| #991361 | Barrier envelopes size 0 | Digital x-ray sensor(Kodak 6100 size 0), inner :36x23mm |
| #991362 | Barrier envelopes size 1 | Digital x-ray sensor(Kodak 6100 size 1), inner :42x26mm |
| #991363 | Barrier envelopes size 2 | Digital x-ray sensor(Kodak 6100 size 2), inner :45x33mm |
| #991364 | Barrier envelopes size 3 | Digital x-ray sensor(Kodak 6100 size 3), inner :56x30mm |
| #991365 | Barrier envelopes size 4 | Digital x-ray sensor(Kodak 6100 size 4), inner :80x60mm |
| #992489 | Tubing sleeves roll (2") | Dental unit tubing, 2",(50mm) |
| #992490 | Tubing sleeves roll (4") | Dental unit tubing, 4",(100mm) |
| #992483 | Barrier film white | Surface area that might be touched during procedure |
| 4"x6", white, 10cmx15cmx180m | ||
| #992482 | Barrier film blue | Surface area that might be touched during procedure |
| 4"x6", blue, 10cmx15cmx180m | ||
| #992585 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, DMD Telicam, |
| 228x43x13.5mm | ||
| #992586 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, Siemens Ceracam/minicam |
| Ultra, 228x43x24mm | ||
| #992587 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, Dentsply Acucap |
| Concept, 228x43x16.6mm | ||
| #992588 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, Camsight OptumII, |
| 228x25x17mm | ||
| #992589 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, RF System SS21, 228x57x22mm |
| #992590 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, Suni Sunic-am,228x48x31mm |
| #992591 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, Digital Doc Iris,228x41x19mm |
| #992592 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, Vision Tools Spectra Vu, |
| 228x57x12mm | ||
| #992593 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, Imagin Hot Rod, |
| 228x50x17.5mm | ||
| #992594 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, Carestream STV Pro I&II Kodak |
| 1000, 228x35x18mm | ||
| #992595 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, Video Dental Concepts |
| Miniscope & Microscope TD-2000,228x53x29mm | ||
| #992596 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, DMD Telicam Digital Doc |
| Aurora, 228x35x22mm | ||
| #991367 | Barrier envelopes size 0 | Digital x-ray sensor (size 0),inner :25x37mm |
| #991368 | Barrier envelopes size 1 | Digital x-ray sensor (size 1),inner :26.5x43mm |
| #991369 | Barrier envelopes size 2 | Digital x-ray sensor (size 2),inner :44x33mm |
| #991374 | Sensor sleeves | Dental instrument tray, 100x43mm |
| #991373 | Sensor sleeves | Dental instrument tray, 250x63mm |
3
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ 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 PRAStaff@fda.hhs.gov
"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."
4
Section 5 510(k) Summary
[As Required by 21 CFR 807.92]
Submitter: BH Medical Products Co., Ltd. No.90 Shenjiang Villagers' group, Zhangjiacunwei, Xilin Street, Zhonglou District, Changzhou City, Jiangsu Province, People's Republic of China (Establishment registration number: 3009307523)
Contact Person: Xiaohua TAO President Tel: 86-519-83978705 Fax: 86-519-83978717 Email: tao@bhmedical.com.cn
US Agent: Name : ISMILE DENTAL PRODUCTS INC. Address : 4201 SIERRA POINT DR STE 102 Sacramento California, 95834 UNITED STATES Contact Person: Bryan Shields Tel: (916) 718-0795 Email: bshields@ismiledp.com
Device/Trade Name: BH Medical Dental Barrier Sleeves and Barrier Film 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 I
Regulation Number: 21 CFR 878.4370 Product Code: PEM
Predicate Device to BH Medical Dental Barrier Sleeves and Barrier Film:
Trade Name: Pac-Dent Barrier Sleeve, Cover-It Barrier Film 510(k) Number: K151123 Manufactured by: Pac-Dent International, Inc.
Device Description:
BH Medical Dental Barrier Sleeves and Barrier Film consist of various sizes and shapes of clear polyethylene covers which are positioned on various small hand-held dental instruments such as hand pieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs,
5
dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.
Indications for Use:
BH Medical Dental 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.
| Item | Model | Description | Designed for |
|---|---|---|---|
| 1 | #992514 | B tray sleeves | Dental instrument tray, 10 1/2"x14"(360x270mm) |
| 2 | #992515 | E tray sleeves | Dental instrument tray, 11 1/2"x16"(410x290mm) |
| 3 | #992516 | A tray sleeves | Dental instrument tray, 7 1/2"x10 |
| 1/2"(270x190mm) | |||
| 4 | #992446 | Headrest Cover | Dental chair headrest, 11"x9 1/2"(250x280mm) |
| 5 | #992447 | Headrest Cover | Dental chair headrest, 14"x9 1/2"(250x360mm) |
| 6 | #992513 | X-ray head sleeves | X-ray head, universal, 15"x26"(660x380mm) |
| 7 | #992481 | Full chair sleeves | Dental chair, universal, 29"x80"(2020x730mm) |
| 8 | #992479 | Half chair sleeves | Half dental chair, universal, 27 |
| 1/2"x24"(680x600mm) | |||
| 9 | #992486 | Syringe/HVE sleeve | |
| without tape | Air/water syringe HVE universal, 2 | ||
| 1/2"x10"(250x60x22mm) | |||
| 10 | #991372 | Digital | |
| x-ray sensor | |||
| sleeve | Digital x-ray sensor, universal, large, 1 | ||
| 5/8"x8"(210x43mm) | |||
| 11 | #991371 | Digital | |
| x-ray sensor | |||
| sleeve | Digital x-ray sensor, universal, large, 1 | ||
| 3/8"x8"(210x36mm) | |||
| 12 | #992492 | handpiece and pen | |
| sleeves-High speed | Dental high-speed handpiece universal(200x28mm) | ||
| 13 | #992493 | handpiece and pen | |
| sleeves-Lower speed | Dental low-speed handpiece universal(200x38mm) | ||
| 14 | #992499 | light handle sleeves | light handles, universal, T-shape(154x73mm) |
| 15 | #992508 | light handle sleeves | light handles, universal, Rectangular(150x105mm) |
| 16 | #992495 | light cure sleeves | Dental curing light, medium,20mm |
| 17 | #992496 | light cure sleeves | Dental curing light, large,25mm |
| 18 | #992497 | light cure sleeves, | |
| curved tip | Dental curing light, medium,(340x53x16mm) | ||
| 19 | #992498 | light cure sleeves, | |
| curved tip | Dental curing light, large,(340x84x16mm) | ||
| 20 | #992582 | light cure sleeves, pen | |
| style | Dental curing light, pen | ||
| type, tip:40x27mm, total:250x50mm | |||
| 21 | #992583 | light cure sleeves, pen style | Dental curing light, pen type,,tip:55x26mm,total:250x52mm |
| 22 | #992584 | light cure sleeves, pen style | Dental curing light, pen type,tip:40x30mm,total:250x55mm |
| 23 | #991361 | Barrier envelopes size 0 | Digital x-ray sensor(Kodak 6100 size 0 ),inner :36x23mm |
| 24 | #991362 | Barrier envelopes size 1 | Digital x-ray sensor(Kodak 6100 size 1 ),inner :42x26mm |
| 25 | #991363 | Barrier envelopes size 2 | Digital x-ray sensor(Kodak 6100 size 2 ),inner :45x33mm |
| 26 | #991364 | Barrier envelopes size 3 | Digital x-ray sensor(Kodak 6100 size 3 ),inner :56x30mm |
| 27 | #991365 | Barrier envelopes size 4 | Digital x-ray sensor(Kodak 6100 size 4 ),inner :80x60mm |
| 28 | #992489 | Tubing sleeves roll (2") | Dental unit tubing, 2",(50mm) |
| 29 | #992490 | Tubing sleeves roll (4") | Dental unit tubing, 4",(100mm) |
| 30 | #992483 | Barrier film white | Surface area that might be touched during procedure 4"x6", white, 10cmx15cmx180m |
| 31 | #992482 | Barrier film blue | Surface area that might be touched during procedure 4"x6",blue,10cmx15cmx180m |
| 32 | #992585 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, DMD Telicam,228x43x13.5mm |
| 33 | #992586 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, Siemens Ceracam/minicam Ultra,228x43x24mm |
| 34 | #992587 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, Dentsply Acucap Concept, 228x43x16.6mm |
| 35 | #992588 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, Camsight OptumII, 228x25x17mm |
| 36 | #992589 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, RF System SS21,228x57x22mm |
| 37 | #992590 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, Suni Sunic-am,228x48x31mm |
| 38 | #992591 | Intraoral Camera Sleeves | Digital intraoral camera sleeves, Digital Doc Iris 228x41x19mm |
| 39 | #992592 | Intraoral Camera | |
| Sleeves | Digital intraoral camera sleeves, Vision Tools | ||
| Spectra Vu,228x57x12mm | |||
| 40 | #992593 | Intraoral Camera | |
| Sleeves | Digital intraoral camera sleeves, Imagin Hot | ||
| Rod,228x50x17.5mm | |||
| 41 | #992594 | Intraoral Camera | |
| Sleeves | Digital intraoral camera sleeves, Carestream STV | ||
| Pro I&II Kodak 1000,228x35x18mm | |||
| 42 | #992595 | Intraoral Camera | |
| Sleeves | Digital intraoral camera sleeves, Video Dental | ||
| Concepts Miniscope & Microscope TD- | |||
| 2000,228x53x29mm | |||
| 43 | #992596 | Intraoral Camera | |
| Sleeves | Digital intraoral camera sleeves, DMD Telicam | ||
| Digital Doc Aurara,228x35x22mm | |||
| 44 | #991367 | Barrier envelopes size 0 | Digital x-ray sensor (size 0),inner :25x37mm |
| 45 | #991368 | Barrier envelopes size 1 | Digital x-ray sensor (size 1),inner :26.5x43mm |
| 46 | #991369 | Barrier envelopes size 2 | Digital x-ray sensor (size 2),inner :44x33mm |
| 47 | #991374 | Sensor sleeves | Dental instrument tray, 100x43mm |
| 48 | #991373 | Sensor sleeves | Dental instrument tray, 250x63mm |
Table for the product names and model numbers:
6
7
Comparison of Technological Characteristics:
| Item | Predicate Device | Subject Device | Comment |
|---|---|---|---|
| Device | Pac-Dent Barrier Sleeve | ||
| 510(K) Number: K151123 | BH Medical Dental Barrier | ||
| Sleeves and Barrier Film | / | ||
| Indications for Use | Pac-Dent Barrier Sleeve are | ||
| intended to be used as a barrier to | |||
| cover dental instruments. It is | |||
| non-sterile and is intended for | |||
| single patient use only. | BH Medical Dental 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. | Same | ||
| Device | |||
| Description | Pac-Dent Barrier Sleeves consist | ||
| of various sizes and shapes of | |||
| clear 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, | BH Medical Dental Barrier | ||
| Sleeves and Barrier Film consist | |||
| of various sizes and shapes of | |||
| clear polyethylene covers which | |||
| are positioned on various small | |||
| hand-held dental instruments such | |||
| as hand pieces, curing lights, | |||
| air/water syringes and similar | |||
| hand instruments. In other forms, | |||
| they are used to cover various | Same | ||
| dental instrument trays, x-ray heads, and others. | devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only. | ||
| Classification | |||
| Product Code | PEM | PEM | Same |
| Material | Polyethylene film | Polyethylene film | Same |
| Material | |||
| Composition | LLDPE(80%),LDPE(20%),Blue pigment(Item#100B,C101B),Adhesive(Item#C101,C101B) | LLDPE(80%),LDPE(20%),Blue pigment(#992482),Adhesive(#992482,#992483) | Same |
| Specifications | |||
| and Tolerances | Paper backing: some of model; | ||
| Film thickness:0.02-0.06mm; | |||
| Tolerance: |