Dental Barrier and Sleeves

K250606 · Yueying Medical Instruments (Langfang) Co., Ltd. · PEM · May 29, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K250606
• Device Name: Dental Barrier and Sleeves
• Applicant: Yueying Medical Instruments (Langfang) Co., Ltd.
• Product Code: PEM · General, Plastic Surgery
• Decision Date: May 29, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

Dental Barrier and 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.

Device Story

Dental Barrier and Sleeves are polyethylene film covers designed to protect dental instruments and equipment from contamination. The device is used in dental clinics by dental professionals. The sleeves are placed over hand-held instruments (e.g., handpieces, curing lights, air/water syringes) and larger equipment (e.g., dental chairs, trays, x-ray heads). By providing a physical barrier, the device reduces the risk of cross-contamination between patients and equipment. The sleeves are disposable and intended for single-patient use. They do not require complex operation; the clinician simply slides the appropriate sleeve over the instrument or equipment before the procedure and removes it afterward. This process helps maintain a hygienic environment and protects both the patient and the equipment.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included synthetic blood penetration (ASTM F1670), viral penetration (ASTM F1671), tear resistance, tensile strength, and puncture resistance. Biocompatibility testing conducted per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-23 (irritation) confirmed the device is non-cytotoxic, non-sensitizing, and non-irritating.

Technological Characteristics

Materials: Polyethylene film (80% LLDPE, 20% LDPE). Dimensions: Various sizes/shapes for specific dental instruments. Connectivity: None. Energy source: None. Sterilization: Non-sterile. Standards: ASTM F1670, F1671, D882, F1342, D1004; ISO 10993-5, 10993-10, 10993-23.

Indications for Use

Indicated for use as a disposable barrier for dental instruments and equipment to prevent cross-contamination. Intended 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

• Dental Barrier and Sleeves (K233918)
• BH Medical Dental Barrier Sleeves and Barrier Film (K190484)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

May 29, 2025

Yueying Medical Instruments (Langfang) Co., Ltd.
% Kiwi Xu
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Central Ave.
Shanghai,
China

Re: K250606
Trade/Device Name: Dental Barrier and Sleeves
Regulation Number: 21 CFR 878.4370
Regulation Name: Surgical Drape And Drape Accessories
Regulatory Class: Class II
Product Code: PEM
Dated: February 28, 2025
Received: February 28, 2025

Dear Kiwi Xu:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K250606 - Kiwi Xu
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

{2}

K250606 - Kiwi Xu
Page 3

assistance/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,


Bobak
Shirmohammadi -S

For Michael E. Adjodha, MChE, RAC, CQIA
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

{3}

Dental Barrier and Sleeves
Page 8 of 28

| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K250606 | ? |
| Please provide the device trade name(s). | | ? |
| Dental Barrier and Sleeves | | |
| Please provide your Indications for Use below. | | ? |
| Dental Barrier and 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. | | |
| Please select the types of uses (select one or both, as
applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

{4}

Yueying Medical Instruments (Langfang) Co., Ltd.

Dong Xiangzhuang Village, Hou Yi Town, Yongqing County, Langfang City, Hebei Province, China

# 510(K) Summary K250606

Document prepared date: 2025/02/10

## A. Applicant:

Yueying Medical Instruments (Langfang) Co., Ltd.

Address: Dong Xiangzhuang Village, Hou Yi Town, Yongqing County, Langfang City, Hebei Province, China

Contact Person: Xiaoliang Wang

Title: General Manager

Tel: [phone]

Fax: [phone]

Email: [e-mail]

Submission Correspondent:

Primary contact: Kiwi Xu

Title: Consultant

Shanghai SUNGO Management Consulting Co., Ltd.

14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China

Tel: [phone]

Email: [e-mail]

Secondary contact: Mr. Raymond Luo

Title: Technical Director

Shanghai SUNGO Management Consulting Co., Ltd.

14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China

Tel: [phone]

## B. Device:

Trade Name: Dental Barrier and Sleeves

Common Name: Dental Barrier and Sleeves

Regulatory Information

Classification Name: Surgical Drape And Drape Accessories

Classification: Class II

Product code: PEM

Regulation Number: 21 CFR 878.4370

## C. Predicate device:

Predicate Device: K190484

K233918

Product name: BH Medical Dental Barrier Sleeves and Barrier Film

Dental Barrier and Sleeves

Manufacturer: BH Medical Products Co., Ltd.

Yongqing Huaguan Dental Instruments Factory

## D. Intended use of the device:

Dental Barrier and Sleeves are intended to be used as a disposable barrier for dental instruments and

{5}

Yueying Medical Instruments (Langfang) Co., Ltd.

Dong Xiangzhuang Village, Hou Yi Town, Yongqing County, Langfang City, Hebei Province, China

equipment. This device is non-sterile and intended for single patient use only.

# E. Device Description:

Dental Barrier and Sleeves consist of various sizes and shapes of 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.

Table for the model numbers and descriptions :

| Item | Model# | Model Description | Designed for |
| --- | --- | --- | --- |
| Models for intra-orally use (Subject to this 510k submission) | | | |
| 1 | HL-6562/HL-6563 | Air/Water Syringe Sleeves | Air/Water Syringe, HVE Universal 2-1/2 " ×10 " |
| 2 | HL-6564 | Month Mirror Covers or Sleeves | Dental Mirror 1-1/2 " ×8 " |
| 3 | HL-6565 | Low Speed Handpiece Sleeves | Dental Low-Speed Handpiece Universal 1-1/2 " ×8 " |
| 4 | HL-6566 | High Speed Handpiece Sleeves | Dental High-Speed Handpiece Universal 1 " ×8 " |
| 5 | HL-6577 | X-Ray Covers | X-Ray Universal 15 " ×26 " |
| 6 | HL-6578 | 3 - function sprayer Sleeves | 3-Fuction Sprayer 7-3/10 " ×5 " |
| 7 | HL-6579 | Scaler Covers | Dental Scaler 1-3/5 " ×8 " |
| 8 | HL-6580 | Intraoral Camera Sheath | Intraoral Camera 9-4/5 " ×2 " |
| 9 | HL-6581 | Digital X-ray Sensor Covers | Digital X-Ray Sensor, Universal 2-1/2 " ×10 " |
| 10 | HL-6582-1 | Digital X-ray Sensor Covers | Digital X-Ray Sensor, Universal 8 " ×1-5/8 " |
| 11 | HL-6582-2 | Digital X-ray Sensor Covers | Digital X-Ray Sensor, Universal 8 " ×1-3/8 " |
| 12 | HL-6585 | Syringe Sleeves (Roll bag) | Syringe 2.2 " ×17.7 " |
| 13 | HL-6586 | Turbine Motor Sleeves (Roll bag) | Turbine 1.8 " ×17.7 " |
| 14 | HL-6588S | Curing Light Sleeves | Dental Curing Light 4.33"X2.95" |
| 15 | HL-6588L | Curing Light Sleeves | Dental Curing Light 4.33"X2.95" |
| 16 | HL-6597 | Curing Light Sleeves | Dental Curing Light 4.7" ×1.2" |
| 17 | HL-6592 | Curing Light Sleeves | Dental Curing Light 13 " ×2.1 " |
| 18 | HL-6593 | Curing Light Sleeves | Dental Curing Light 13 " ×3.3 " |
| 19 | HL-6594 | Intraoral Camera Sleeve | Intraoral Camera 10.2 " ×2 " |
| 20 | HL-6595 | Curing Light Sleeves | Dental Curing Light 9.9"X1.85" |
| 21 | HL-6596 | Curing Light Sleeves | Dental Curing Light 12.4"X4.13" |
| 22 | HL-6604 | Disposable Barrier Sleeves | Barrier Sleeve 9.25 " ×3.15 " |
| 23 | HL-6605 | Disposable Barrier Sleeves | Barrier Sleeve 11.2 " ×2.2 " |

{6}

Yueying Medical Instruments (Langfang) Co., Ltd.

Dong Xiangzhuang Village, Hou Yi Town, Yongqing County, Langfang City, Hebei Province, China

| 24 | HL-6606 | Disposable Barrier Sleeves | Barrier Sleeve 11.2 " ×2.2 " |
| --- | --- | --- | --- |
| 25 | HL-6607 | Low Speed Handpiece Cover | Low Speed Handpiece 7.5 " ×1.53 " |
| 26 | HL-6608 | X-ray sensors Cover | X-Ray Sensor 8 " ×1-5/8 " |
| 27 | HL-6610 | Digital Sensor Envelopes | Dightal Sensor 2"X4.5" |
| 28 | HL-6611 | Digital Sensor Envelopes | Dightal Sensor 1-5/8"X4" |
| 29 | HL-6612 | Digital Sensor Envelopes | Dightal Sensor 1.6"X4.5" |
| 30 | HL-6613 | Digital Sensor Envelopes | Dightal Sensor 1.4"X4.3" |
| 31 | HL-6614 | Bite Block Covers | Bite Block 1.4"X2.5" |
| 32 | HL-6615 | Intraoral Camera Sleeve | Intraoral Camera 35mm*110mm |
| 33 | HL-6579S | Scaler Covers | Dental Scaler 1.4 " ×7 " |
| 34 | HL-6701 | Fitted Digital Sensor Sleeves | Digital Sensor 2" ×9.124" |
| 35 | HL-20963 | Intraoral Camera Sheath | Intraoral Camera 220mm*48mm |
| 36 | HL-21013 | Intraoral Camera Sheath | Intraoral Camera 210*57mm |
| 37 | HL-20855 | Intraoral Camera Sheath | Intraoral Camera 228mm*57mm |
| 38 | HL-20999 | X-ray Sensor Sheath | Digital X-Ray Sensor(Dexis) Compatible TIDI:20999 225mm*57mm |
| 39 | HL-20978 | X-ray Sensor Sheath | Digital X-Ray Sensor(Kodak 6100 Size 1)Compatible TIDI:20978 226mm*57mm |
| 40 | HL-20824 | X-ray Sensor Sheath | For SCHICK Size 1 Compatible TIDI:20824 220mm*47mm |
| 41 | HL-20861 | X-ray Sensor Sheath | Digital Sensor 223mm*57mm |
| 42 | HL-20825 | X-ray Sensor Sheath | For SCHICK Size 2 Compatible TIDI:20825 220mm*57mm |
| 43 | HL-20979 | X-ray Sensor Sheath | Digital X-Ray Sensor(Kodak 6100 Size 2) 223mm*56mm |
| 44 | HL-20831 | Intraoral Camera Sheath | Intraoral Camera 225mm*55mm |
| 45 | HL-6577A | X-ray Barrier | X-Ray 23" X 31 " |
| 46 | HL-6577B | X-ray Barrier | X-Ray 14" X 13" X 24.5" |
| 47 | HL-100 | Barrier Film | Surface Area That Might Be Touched During Procedure 4"X6" |
| 48 | HL-101 | Barrier Film Blue | Surface Area That Might Be Touched During Procedure 4"X6" |
| 49 | HL- A Size 0 | X-ray Barrier Envelopes | Phosphor Plates Size 0 Inner: 22×35mm |
| 50 | HL- A Size 1 | X-ray Barrier Envelopes | Phosphor Plates Size 1 Inner:24mmx40mm |
| 51 | HL- A Size 2 | X-ray Barrier Envelopes | Phosphor Plates Size 2 Inner:31mmx41mm |
| 52 | HL- A Size 3 | X-ray Barrier Envelopes | Phosphor Plates Size 3 Inner: 27mmx54mm |
| 53 | HL- A Size 4 | X-ray Barrier Envelopes | Phosphor Plates Size 4 Inner: 57mmx76mm |
| 54 | HL- B Size 0 | X-ray Barrier Envelopes | Phosphor Plates Size 0 Inner: 22×35mm |

3 of 8

{7}

Yueying Medical Instruments (Langfang) Co., Ltd.

Dong Xiangzhuang Village, Hou Yi Town, Yongqing County, Langfang City, Hebei Province, China

| 55 | HL- B Size 1 | X-ray Barrier Envelopes | Phosphor Plates Size 1 Inner:24mmx40mm |
| --- | --- | --- | --- |
| 56 | HL- B Size 2 | X-ray Barrier Envelopes | Phosphor Plates Size Inner:31mmx41mm |
| 57 | HL- B Size 3 | X-Ray Barrier Envelopes | Phosphor Plates Size 3 Inner: 27mmx54mm |
| 58 | HL- B Size 4 | X-Ray Barrier Envelopes | Phosphor Plates Size 4 Inner: 57mmx76mm |
| 59 | IC-001 | Intraoral Camera Sleeves | Intraoral Camera 1” HEAD X 2” OPENING X 8.25” LENGTH |
| 60 | IC-085 | Intraoral Camera Sleeves | Intraoral Camera 0.85” HEAD X 1.75” OPENING X 8.25” LENGTH |
| 61 | PS-00/01 | Digital Sensor Cover | Dental Sensor 9"L * 1-3/4"W |
| 62 | PS-002 | Comfort Sensor Sleeves | Dental Sensor 9"L*2"W |
| 63 | PS-5500 | Perforated Bite Block Covers | Bite Block 1"W * 2"L |
| 64 | PS-5501 | Perforated Bite Block Covers | Bite Block 1 1/2"W X 3"L |
| 65 | PS-5502 | Large Digital Sensor Covers | Digital Sensor 2-3/4"W * 8"L |
| 66 | PS-5505 | Universal Digital Sensor Covers | Digital Sensor 1-1/2"W *7"L |
| 67 | PS-5511 | Large Comfort Sensor Covers | Dental Sensor 2"W *4-1/2"L |
| 68 | PS-5522 | Comfort Sensor Covers, #2 | Dental Sensor 1-5/8"W * 4-1/8"L |
| 69 | PS-5533 | Comfort Sensor Covers, #0/#1 | Dental Sensor 1-3/8"W * 4-1/4"L |
| 70 | PS-CYGNUS-1 | Digital Sensor Sleeves Cygnus#1 | Digital Dental Sensor 24*3.5 |
| 71 | PS-DEXIS-U | Digital Sensor Sleeves Dexis Universal | Digital Dental Sensor 9.5"*1.77" |
| 72 | PS308 | Air/Water Syringe Cover | Air Water Syringe 2 ½” X 8 ¼” |
| 73 | PS321 | Air/Water Syringe Cover (¾” Seal) | Air Water Syringe 2 ½” X10” |
| 74 | PS3767-WO | Air/Water Syringe Cover (Notched) | Air Water Syringe 2 ½” X10" |
| 75 | PS4500 | Curing Light Tip Sleeves | Curing Light FOR 7-8mm TIP STICK HOLD |
| 76 | PS4511 | Curing Light Tip Sleeves | Curing Light FOR 11mm TIP STICK HOLD |
| 77 | PS4700 | Cordless Curing Light Cover | Curing Light 1 ¾” X 9 ¾” |
| 78 | PS4701 | Cordless Curing Light Cover | Curing Light 2" X 12 ¾” |
| 79 | PS4707 | Cordless Curing Light Cover | Curing Light 4" X 12 ½” |
| 80 | PS4708 | Cordless Curing Light Cover | Curing Light 3 ¼” X 13" |
| 81 | PS730 | Scaler Sleeves-Stick Hold | Dental Scaler Stick Hold 1-1/2"W*7"L |
| 82 | PS735 | Scaler Sleeves | Dental Scaler 1-5/8” X 8" |
| 83 | XS-6100-0 | Digital Sensor Sheath For Kodak Size 0 | Digital Sensor 24*3.5 |
| 84 | XS-6100-1 | Digital Sensor Sheath For Kodak Size 1 | Digital Sensor 24*4.3 |
| 85 | XS-6100-2 | Digital Sensor Sheath For | Digital Sensor 24*4.3 |

4 of 8

{8}

Yueying Medical Instruments (Langfang) Co., Ltd.

Dong Xiangzhuang Village, Hou Yi Town, Yongqing County, Langfang City, Hebei Province, China

| | | Kodak Size 2 | |
| --- | --- | --- | --- |
| 86 | XS-CYGNUS-1 | Digital Sensor Sheath For Cygnus Size 1 | Digital Sensor 24*3.5 |
| 87 | XS-DEXIS-2 | Digital Sensor Sheath For Dexis Size 2 | Digital Sensor 24*3.9 |
| 88 | XS-DEXIS-U | Digital Sensor Sheath For Dexis Universal | Digital Sensor |
| 89 | XS-GXDR-1 | Digital Sensor Sheath For Gendex/Xdr Size 1 | Digital Sensor 24*3.4 |
| 90 | XS-GXDR-2 | Digital Sensor Sheath For Gendex/Xdr Size 2 | Digital Sensor 24*3.9 |
| 91 | XS-SHICK-1 | Digital Sensor Sheath For Schick Size 1 | Digital Sensor 24*3.5 |
| 92 | XS-SHICK-2 | Digital Sensor Sheath For Schick Size 2 | Digital Sensor 24*4.3 |
| 93 | SS100 | Single Syringe Sleeves | Single Syringe 210mm*51mm*0.0275 |
| 94 | SS200 | Automix Syringe Sleeves | Automix Syringe 235mm*65mm*0.0275 |
| Models for non intra-orally use | | | |
| 95 | HL-6567 | T Light Handle Covers | Light Handle For T-Style 4 " L×5-3/4 " W |
| 96 | HL-6568 | Tray Sleeves | Dental Instrument Tray 11-5/8 " ×16 " |
| 97 | HL-6569 | Tray Sleeves | Dental Instrument Tray 10-1/2 " ×14 " |
| 98 | HL-6569S | Tray Sleeves | Dental Instrument Tray 7 1/2 " ×10 1/2 " |
| 99 | HL-6571 | Headrest Covers | Dental Chair Headrest 11"X10" |
| 100 | HL-6572 | Headrest Covers | Dental Chair Headrest 14"X10" |
| 101 | HL-6573-1 | Half Chair Covers | Half Dental Chair 27-1/2 " ×24 " |
| 102 | HL-6573-2 | Half Chair Covers | Half Dental Chair 32 " ×32 " |
| 103 | HL-6574/HL-6576 | Full Chair Covers | Full Dental Chair 29 " ×80 " |
| 104 | HL-6575 | Full Chair Covers | Wide Full Dental Chair 48 " ×56 " |
| 105 | HL-6583 | T Light Handle Covers | Light Handle Cover 6 " ×2-9/10 " |
| 106 | HL-6587 | Headrest Covers (Roll bag) | Dental Chair Headrest 11.8 " ×9 " |
| 107 | HL-6601 | PC mouse Covers | PC Mouse 6.25 " ×3.5 " |
| 108 | HL-6702 | Keyboard Covers | Keyboard 22"X13.78" |
| 109 | HL-6568-2 | Tray Barriers | Dental Instrument Tray 11-5/8" X 14" Size A |
| 110 | HL-6569-2 | Tray Barriers | Dental Instrument Tray 11.5" X 16" Size E |
| 111 | HL-7510 | Tray Barriers | Dental Instrument Tray 7.5" X 10.5" Size F |
| 112 | HL-7521 | Keyboard Cover | Keyboard 22" X 14" |
| 113 | PS101 | Small Half Chair Cover | Dental Chair 20"W X 30"L |
| 114 | PS105 | Full Chair Cover | Dental Chair 33"W X 54"L |
| 115 | PS203 | Size E Tray Cover W/Lock Top | Plastice/Metal Trays 11-1/2"*16" |

{9}

Yueying Medical Instruments (Langfang) Co., Ltd.

Dong Xiangzhuang Village, Hou Yi Town, Yongqing County, Langfang City, Hebei Province, China

| 116 | PS328T | T-Shape Lite Handle Cover | T-Shape Lite Handle 6"W X 3"L |
| --- | --- | --- | --- |
| 117 | PS408 | Wireless Keyboard Covers | Keyboard 24"Lx 10"W |
| 118 | PS410-STWD | Wide Lcd Cover | Monitor And Keyboard 25"WX16"L W/3" POCKET |
| 119 | PS410-WD | Wide Lcd+Keyboard Cover | Monitor And Keyboard 25"W*26"Lw/3"POCKET |
| 120 | PS670 | Chair Armrest Covers | Chair Armrest 24"Lx6"W |
| 121 | PS680 | Jumbo Headrest Cover | Chair Headrest 14 1/2"L X 14 3/4"W |

F. Comparison with predicate device

| Device | Subject Device | Predicate Device | | Comment |
| --- | --- | --- | --- | --- |
| Manufacturer | Yueying Medical Instruments (Langfang) Co., Ltd. | Yongqing Huaguan Dental Instruments Factory | BH Medical Products Co., Ltd. | / |
| 510K number | - | K233918 | K190484 | / |
| Product Name | Dental Barrier and Sleeves | Dental Barrier and Sleeves | BH Medical Dental Barrier Sleeves and Barrier Film | / |
| Classification | Class II Device (21 CFR 878.4370) | Class II Device (21 CFR 878.4370) | Class II Device (21 CFR 878.4370) | Same |
| Intended use | Dental Barrier and 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 | Dental Barrier and 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 | 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 | Dental Barrier and Sleeves consist of various sizes and shapes of 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 | Dental Barrier and Sleeves consist of various sizes and shapes of 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 | 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 | Same |

{10}

Yueying Medical Instruments (Langfang) Co., Ltd.

Dong Xiangzhuang Village, Hou Yi Town, Yongqing County, Langfang City, Hebei Province, China

| Device | Subject Device | Predicate Device | | Comment |
| --- | --- | --- | --- | --- |
| | 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. | 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. | 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. | |
| Classification Product Code | PEM | PEM | PEM | Same |
| Material | Polyethylene film | Polyethylene film | Polyethylene film | Same |
| Material Composition | LLDPE(80%),LDPE(20%) | LLDPE(80%),LDPE(20%) | LLDPE(80%),LDPE(20%),Blue pigment(#992482),Adhesive(#992 482,#992483) | Same |
| Specifications and Tolerances | Paper Backing: Some of the model; Film Thickness: 0.02-0.06mm Tolerance:<0.01mm | Paper Backing: Some of the model; Film Thickness: 0.02-0.06mm Tolerance:<0.01mm | Paper Backing: No Film Thickness: 0.025mm Tolerance:<0.01mm | Similar |
| Labeling | Single use device | Single use device | Single use device | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Performance Properties | Synthetic Blood Penetration test (ASTM F1670) -Pass Viral Penetration test (ASTM F1671)-Pass | Synthetic Blood Penetration test (ASTM F1670) -Pass Viral Penetration test (ASTM F1671)-Pass | Synthetic Blood Penetration test (ASTM F1670) -Pass Viral Penetration test (ASTM F1671)-Pass | Same |
| Biocompatibility | Biocompatibility tests were conducted in compliance with ISO 10993-5, ISO 10993-10 and ISO 10993-23 Test results indicate the device is | Biocompatibility tests were conducted in compliance with ISO 10993-5, ISO 10993-10 and ISO 10993-23 Test results indicate the device is | Biocompatibility tests were conducted in compliance with ISO 10993-5 and ISO 10993-10. Test results indicate the | Same |

{11}

Yueying Medical Instruments (Langfang) Co., Ltd.
Dong Xiangzhuang Village, Hou Yi Town, Yongqing County, Langfang City, Hebei Province, China

| Device | Subject Device | Predicate Device | | Comment |
| --- | --- | --- | --- | --- |
| | non-cytotoxic, non-sensitizing and non-irritating. | non-cytotoxic, non-sensitizing and non-irritating. | device is non-cytotoxic, non-sensitizing and non-irritating. | |
| Dimensions | Difference in dimensions is due to the size of instruments and equipment they cover | Difference in dimensions is due to the size of instruments and equipment they cover | Difference in dimensions is due to the size of instruments and equipment they cover | Same |
| FDA-Recognized Standards | ASTM F1670 | ASTM F1670 | ASTM F1670 | Same |
| | ASTM F1671 | ASTM F1671 | ASTM F1671 | |
| | ASTM D882 | ASTM D882 | ASTM D882 | |
| | ASTM F1342 | ASTM F1342 | ASTM F1342 | |
| | ASTM D1004 | ASTM D1004 | ASTM D1004 | |
| | ISO 10993-5 | ISO 10993-5 | ISO 10993-5 | |
| | ISO 10993-10 | ISO 10993-10 | ISO 10993-10 | |
| | ISO 10993-23 | ISO 10993-23 | | |

## Substantial Equivalence Discussion:

The subject and predicate devices have the same intended use. Both are single-use devices, and material and performance characteristic are identical. The minor differences in specifications and tolerances between the subject and predicate devices do not raise questions of safety and effectiveness.

## G. Non-Clinical Testing

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 and ISO 10993-23 has been performed. Effectiveness of x-ray devices covered with Dental Barrier and Sleeves were 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.

## H. Clinical Test Conclusion

No clinical study is included in this submission.

## I. Conclusion

Based on the comparison and analysis above, the subject device, Dental Barrier and Sleeves, is as safe, as effective, and performs as well as the legally marketed predicate devices.

8 of 8