Who is the manufacturer of Nitrile Patient Examination Glove?

Yunnan Huazhiyuan Medical Technology Co., Ltd. filed the 510(k) submission for Nitrile Patient Examination Glove (K210686).

What is the FDA product code for Nitrile Patient Examination Glove?

LZA. It is classified under 21 CFR 880.6250 as a Class 1 device in the General Hospital panel.

What is the regulatory pathway for Nitrile Patient Examination Glove?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Nitrile Patient Examination Glove?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Nitrile Patient Examination Glove

K210686 · Yunnan Huazhiyuan Medical Technology Co., Ltd. · LZA · Jul 21, 2021 · General Hospital

Device Facts

Record ID	K210686
Device Name	Nitrile Patient Examination Glove
Applicant	Yunnan Huazhiyuan Medical Technology Co., Ltd.
Product Code	LZA · General Hospital
Decision Date	Jul 21, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6250
Device Class	Class 1

Intended Use

The Nitrile Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Story

Nitrile patient examination glove; disposable; non-sterile; blue color; ambidextrous design. Worn by healthcare examiners to provide a barrier against contamination between patient and examiner. Manufactured from nitrile material. Device provides physical protection during medical examinations. No electronic, software, or algorithmic components. Used in clinical or medical environments.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified via ASTM D6319 (physical dimensions/properties), ASTM D5151 (watertightness/holes), ASTM D6124 (residual powder), and ISO 10993 (biocompatibility: cytotoxicity, irritation, sensitization).

Technological Characteristics

Material: Nitrile. Form factor: Ambidextrous, powder-free, non-sterile, blue. Dimensions: XS-XXL sizes, thickness ≥0.05mm (finger/palm). Standards: ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ISO 10993-5, ISO 10993-10. No energy source, connectivity, or software.

Indications for Use

Indicated for use as a disposable, non-sterile, powder-free glove worn on the examiner's hands to prevent contamination between patient and examiner in medical settings.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color (K171422)

Related Devices

K210691 — Disposable Nitrile Medical Examination Glove · Jiangsu Cureguard Glove Co., Ltd. · Jul 30, 2021
K222527 — Nitrile Patient Examination Glove · Pingan Medical Products Co., Ltd. · Dec 14, 2022
K211540 — Edma Synthetic Nitrile Examination Gloves · Edma Group, LLC · Aug 9, 2021
K171093 — STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE · Sanrea Healthcare Products Pvt, Ltd. · Jul 19, 2017
K143477 — Nitrile Patient Examination gloves, Powderfree, Blue color · Primus Gloves Pvt Limited · Apr 14, 2016

Submission Summary (Full Text)

{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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. July 21, 2021 Yunnan Huazhiyuan Medical Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China Re: K210686 Trade/Device Name: Nitrile Patient Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 18, 2021 Received: June 23, 2021 Dear Boyle Wang: 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 {1}------------------------------------------------ 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 mediation-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 Clarence Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210686 Device Name Nitrile Patient Examination Glove Indications for Use (Describe) The Nitrile Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | 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 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." {3}------------------------------------------------ # 510(k) Summary (K210686) This summary of 510(k) is being submitted in accordance with 21 CFR 807.92. #### 1.0 Submitter's Information Yunnan Huazhiyuan Medical Technology Co., Ltd. Name: Address: Yangjie Industrial Park,Jianshui County,Honghe Hani and Yi Autonomous Prefecture, Yunnan Province,China Phone Number: +86-18252909158 Contact: Yun Gao Date of Preparation: Jun.18th,2021 #### Designated Submission Correspondent Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn #### 2.0 Device Information Trade name: Nitrile Patient Examination Glove Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS,S, M, L, XL,XXL #### 3.0 Classification Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital #### 4.0 Predicate Device Information Manufacturer: Ever Global (Vietnam) Enterprise Corp Device: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color 510(k) number: K171422 {4}------------------------------------------------ ## 5.0 Indication for Use The Nitrile Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. #### 6.0 Device Description The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile. ### 7.0 Technological Characteristic Comparison Table | Item | Subject Device (K210686) | Predicated Device (K171422) | Remark | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Product Code | LZA | LZA | Same | | Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same | | Class | | | Same | | Indications for use | The Nitrile Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiners hands or finger to prevent contamination between patient and examiner. | Same | | Powdered or Powered free | Powdered free | Powdered free | Same | | Design Feature | Ambidextrous | Ambidextrous | Same | | Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile | Same | #### Table1-General Comparison #### Table2 Device Dimensions Comparison | Predicate | Designation | Size | Tolerance | |-----------|-------------|------|-----------| | | | | | {5}------------------------------------------------ | Device(K171422) | Length, mm | XS | S | M | L | XL | | | |-----------------------------|----------------|------|-----|-----|-----|-----|-----|-----------| | | | 230 | 230 | 230 | 230 | 230 | min | | | | Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | | | | Thickness, mm: | | | | | | | | | | Finger | 0.05 | | | | | min | | | | Palm | 0.05 | | | | | min | | | Subject Device (K210686) | Designation | XS | S | M | L | XL | XXL | Tolerance | | | Length, mm | 220 | 220 | 230 | 230 | 230 | 230 | min | | | Width, mm | 70 | 80 | 95 | 110 | 120 | 130 | ±10 | | | Thickness, mm: | | | | | | | | | | Finger | 0.05 | | | | | | min | | | Palm | 0.05 | | | | | | min | | Remark | SIMILAR | | | | | | | | Analysis: The physical dimensions are little different with that of the predicate, but they all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions. | Item | Subject device (K210686) | Predicated device (K171422) | Remark | | | |------------------------|-----------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|------------|------| | Colorant | Blue | White/ Blue/ Black/ Pink | Same | | | | Physical Properties | Before Aging | Tensile Strength | 14MPa, min | 14MPa, min | Same | | | | Ultimate Elongation | 500% min | 500% min | Same | | | After Aging | Tensile Strength | 14MPa, min | 14MPa, min | Same | | | | Ultimate Elongation | 400%min | 400%min | Same | | Comply with ASTM D6319 | | | Comply with ASTM D6319 | Same | | | Freedom from Holes | | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Same | | | Powder Content | | Meet the requirements of | Meet the requirements | Same | | ### Table3 Performance Comparison {6}------------------------------------------------ | ASTM D6124 | of D6124 | ASTM | |------------|-------------|------| |------------|-------------|------| #### Table4 Safety Comparison | Item | | Subject device (K210686) | Predicated device (K171422) | Remark | |------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------|---------| | | | Material | | Nitrile | | Biocompatibility | Irritation (ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization) | Under the conditions of the study, not an irritant | | | | | Sensitization (ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization) | Under conditions of the study, not a sensitizer. | Comply with ISO10993-10 | Same | | | Cytotoxicity (ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity) | Under conditions of the study, / device extract is not cytotoxic | / | Similar | #### 8.0 Summary of Non-clinical Testing Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards: ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves {7}------------------------------------------------ ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. | Test Method | Purpose | Acceptance Criteria | Results | | | |-----------------|-----------------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | ASTM D6319 | Physical Dimensions Test | Length(mm): XS/S:≥220; M/L/XL/XXL:≥230; | Length: XS/S: > 220/Pass; M/L/XL/XXL: > 230/Pass; | | | | | | Width(mm): XS:70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10; XXL: 130±10 | Width (mm): XS:73-78/Pass S: 80-84 /Pass M: 95-100/ Pass L: 109-114/ Pass XL:117-121/ Pass XXL: 125-128/ Pass | | | | | | Thickness (mm): Finger: ≥0.05 Palm: ≥0.05 | Finger: 0.08-0.13/Pass Palm: 0.08-0.13/Pass | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125,1/124, 0/125, 0/125, 0/125, 0/125 leaks / Pass | | | | ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | XS:0.04mg/Pass; S: 0.06mg/Pass; M: 0.06mg/Pass; L: 0.08mg/Pass; XL: 0.07mg/Pass; XXL: 0.10mg/Pass. | | | | ASTM D412 | Physical properties | Before Aging | Tensile Strength ≥14MPa | XS:15-17/Pass; S:15-20/Pass; M:15-18/Pass; L:15-18/Pass; XL:15-18/Pass; XXL:16-20/Pass. | | | | | | Ultimate Elongation ≥500% | XS:540-561/Pass; S:530-571/Pass; | | | | | | | | | | ISO 10993-5 | Cytotoxicity | Non-cytotoxic | | Under conditions of the study, did not show potential toxicity to L-929 cells./ Pass | | | ISO 10993-10 | Irritation | Non-irritating | | Under the conditions of the study, not an irritant/ Pass | | | ISO 10993-10 | Sensitization | Non-sensitizing | | Under conditions of the study, not a sensitizer / Pass | | | | | After Aging | Tensile Strength | ≥14MPa | XS:15-17/Pass; S:15-17/Pass; M:15-17/Pass; L:15-18/Pass; XL:14-19/Pass; XXL:15-27/Pass | | | | | Ultimate Elongation | ≥400% | XS:545-570/Pass; S:538-570/Pass; M:525-570/Pass; L:525-570/Pass; XL:525-570/Pass; XXL:510-560/Pass. | | | | | | | M:525-575/Pass; L:520-565/Pass; XL:520-570/Pass; XXL:530-580/Pass | Table 5 - Summary of non-clinical performance testing {8}------------------------------------------------ #### 9.0 _Summary of Clinical Testing Clinical testing is not needed for this device. #### 10.0 Conclusion The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.

Nitrile Patient Examination Glove

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

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Nitrile Patient Examination Glove

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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