Who is the manufacturer of Medical nitrile examination gloves (Model: JL001)?

Guangdong Jiali Pharmaceutical Co.,Ltd filed the 510(k) submission for Medical nitrile examination gloves (Model: JL001) (K213848).

What is the FDA product code for Medical nitrile examination gloves (Model: JL001)?

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 Medical nitrile examination gloves (Model: JL001)?

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

What are the predicate devices for Medical nitrile examination gloves (Model: JL001)?

Patient Examination Gloves (K203593).

Who can help prepare an FDA 510(k) submission like Medical nitrile examination gloves (Model: JL001)?

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.

Medical nitrile examination gloves (Model: JL001)

K213848 · Guangdong Jiali Pharmaceutical Co.,Ltd · LZA · Mar 25, 2022 · General Hospital

Device Facts

Record ID	K213848
Device Name	Medical nitrile examination gloves (Model: JL001)
Applicant	Guangdong Jiali Pharmaceutical Co.,Ltd
Product Code	LZA · General Hospital
Decision Date	Mar 25, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6250
Device Class	Class 1

Intended Use

The Medical nitrile examination gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

Device Story

Medical nitrile examination gloves (Model: JL001) are single-use, non-sterile, powder-free nitrile rubber gloves. Designed for use by healthcare examiners to prevent cross-contamination between patient and examiner. Features include blue color (Pigment Blue), smooth surface, and rolled cuff rim. Available in sizes S, M, L, and XL. Device is worn on hands during clinical examinations. Benefits include barrier protection against contaminants. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only. Testing included physical dimensions, tensile strength, ultimate elongation (before/after aging), freedom from holes (ASTM D5151), and residual powder (ASTM D6124), all meeting ASTM D6319-19 requirements. Biocompatibility testing included skin irritation, skin sensitization (ISO 10993-10), and acute systemic toxicity (ISO 10993-11), all passing.

Technological Characteristics

Material: Nitrile rubber. Color: Blue (Pigment Blue CAS 147-14-8). Form factor: Smooth surface, rolled rim cuff. Sizes: S, M, L, XL. Standards: ASTM D6319-19 (dimensions, physical properties, freedom from holes, powder content). Biocompatibility: ISO 10993-10, ISO 10993-11. Sterilization: Non-sterile. Connectivity: None. Energy source: None.

Indications for Use

Indicated for use by examiners to prevent contamination between patient and examiner. Single-use, powder-free, non-sterile device for general patient examination.

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

Patient Examination Gloves (K203593)

Related Devices

K212840 — Nitrile Gloves (Model: NE01) · Byd Auto Industry Company Limited · Dec 11, 2021
K211927 — Nitrile examination gloves · Fitone Latex Products Co., Ltd. Guangdong · Oct 12, 2021
K212722 — Nitrile Examination Gloves · Wuhan Huirui Technology Co., Ltd. · Nov 26, 2021
K213739 — Nitrile Examination Gloves · Hangzhou Runheng Medical Co., Ltd. · Jun 22, 2022
K211319 — Purism Non-Sterile Powder Free Nitrile Examination Gloves · Dezhou Purism Medical Technology Co., Ltd. · Aug 19, 2021

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 25, 2022 Guangdong Jiali Pharmaceutical Co.,Ltd % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920. Building D3, Miniie Plaza, Shuixi Road, Huang District Guangzhou, Guangdong China Re: K213848 Trade/Device Name: Medical nitrile examination gloves (Model: JL001) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: February 14, 2022 Received: February 18, 2022 Dear Cassie Lee: 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 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. Bifeng Qian, M.D., Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213848 Device Name Medical nitrile examination gloves (Model: JL001) Indications for Use (Describe) The Medical nitrile examination gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. | 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 K213848 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. ## 1. Date of the summary prepared: March 15, 2022 ## 2. Submitter's Information Sponsor Name: Guangdong Jiali Pharmaceutical Co.,Ltd Address: Dawei, Niuqutian Villagers Committee, Muzhou Town, Xinhui, Jiangmen,Guangdong,China Post Code: 529143 Contact name: Jiali Chen Tel: +86-0750-3835982 Tel: +86-15988225228 E-mail: 275119024@gq.com ## Application Correspondent: Contact Person: Ms. Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minije Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8200 6973 Email: regulatory@share-info.com # 3. Subject Device Information Type of 510(k): Traditional Common Name: Polymer Patient Examination Glove Classification Name: Non-powdered patient examination glove Trade Name: Medical nitrile examination qloves Model Name: JL001 Review Panel: General Hospital Product Code: LZA Requlation Number: 21 CFR 880.6250 Requlatory Class: Class I ## 4. Predicate Device Information Sponsor: Guang Dong Kingfa SCI. & TECH.CO., LTD. Common Name: Polymer Patient Examination Glove {4}------------------------------------------------ Classification Name: Non-Powdered Patient Examination Glove Trade Name: Patient Examination Gloves 510(k) Number: K203593 Review Panel: General Hospital Product Code: LZA Regulation Number: 21 CFR 880.6250 Regulatory Class: Class I ## 5. Device Description The subject device is a powder-free nitrile examination glove, provided as a non-sterile and disposable device. The subject device is mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface and has a rolled rim at the cuff edge. ## 6. Intended Use / Indications for Use The Medical nitrile examination gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device. | 7. Comparison to predicate device and conclusion | | | |--------------------------------------------------|--|--| |--------------------------------------------------|--|--| | Elements of Comparison | Subject Device | Predicate Device | Result | |---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------| | Company | Guangdong Jiali Pharmaceutical Co.,Ltd | Guang Dong Kingfa SCI. & TECH.CO., LTD. | -- | | 510 (k) Number | K213848 | K203593 | -- | | Trade Name | Medical nitrile examination gloves | Patient Examination Gloves | -- | | Product Code | LZA | LZA | -- | | Classification Name | Non-Powdered Patient Examination Glove | Non-Powdered Patient Examination Glove | Same | | Classification | Class I | Class I | Same | | Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | | Indications For Use | The Medical nitrile examination gloves is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a | The nitrile examination glove is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single- | Same | | Elements of Comparison | Subject Device | Predicate Device | Result | | | single-use, powder-free, non- sterile device. | single-use, powder-free, non-sterile device. | | | Material of Use | Nitrile rubber | Nitrile rubber | Same | | Color | Blue | Blue | Same | | Texture | No | Finger Textured | Different Note | | Size (ASTM D6319-19) | Small, Medium, Large, X Large | Small, Medium, Large, X Large | Same | | Sterilization | Non-sterile | Non-sterile | Same | | Usage | Single usage | Single usage | Same | | Dimensions (ASTM D6319-19) | Length: For S: ≥220 mm For M/L/XL: ≥230 mm | Length: S (220mm min) M (230mm min) L (230mm min) XL (230mm min) | Same | | | Width: For S: 80±10mm For M: 95±10 mm For L: 110±10 mm For XL: 120±10 mm | Palm width: Small (80±10mm) Medium (95±10mm) Large (110±10mm) X large (120±10mm) | | | Physical Properties (ASTM D6319-19) | Meets requirements of the ASTM D6319-19 Before Aging: Tensile Strength: ≥14Mpa Ultimate Elongation: ≥500% | Meets requirements of the ASTM D6319-19 Before Aging: Tensile Strength: Min 14 Mpa Ultimate Elongation: Min 500% | Same | | | Meets requirements of the ASTM D6319-19 After Aging: Tensile Strength: ≥14Mpa Ultimate Elongation: ≥400% | Meets requirements of the ASTM D6319-19 After Aging: Tensile Strength: Min 14Mpa Ultimate Elongation: Min 400% | | | Thickness (ASTM D6319-19) | Palm min. 0.05 mm Finger min. 0.05 mm | Palm min. 0.05 mm Finger min. 0.05 mm | Same | | Powder Free (ASTM D6319-19) | ≤2 mg/glove | ≤2 mg/glove | Same | | Elements of Comparison | Subject Device | Predicate Device | Result | | Freedom from Holes (Water Tight -1000 ml)-ASTM D6319-19 (Cross Reference D5151) | Meets requirements of the ASTM D6319-19 | Meets requirements of the ASTM D6319-19 | Same | | Biocompatibility - Skin Sensitization (ISO 10993-10:2010) | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer | Same | | Biocompatibility - Skin Irritation (ISO 10993-10:2010) | Under the conditions of study not an irritant | Under the conditions of study not an irritant | Same | | Biocompatibility - Acute Systemic Toxicity (ISO 10993- 11: 2017) | Cytotoxicity is assessed via rationale. Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo. | Cytotoxicity is assessed via rationale. Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo. | Same | {5}------------------------------------------------ {6}------------------------------------------------ # Comparison in Detail(s): # Note: Although the subject device has no texture, which is different from the predicate device, both the performance of the subject device and predicate device met the requirements of the standard ASTM D6319-19. So, the difference between the subject device and predicate device will not affect the safety and effectiveness. # 8. Test Summary # 8.1 Summary of Non-Clinical Performance Testing #### 1) Performance Testing Summary: | Test Method | Test Purpose | Acceptance Criteria | Test Results | Conclusion | |---------------------|------------------|------------------------|----------------|------------| | ASMT D6319-19 | To determine the | Width: | Lot Batch of | Passed | | Standard | width, length, | For S: $80\pm10$ mm | 20210716A: | | | Specification for | and thickness of | For M: $95\pm10$ mm | Width: | | | Nitrile Examination | the gloves | For L: $110\pm10$ mm | For S: 79~83mm | | | Gloves for Medical | | For XL: $120\pm10$ mm | For M: 93~97mm | | {7}------------------------------------------------ | Application - Physical Dimensions Test | Length: For S: ≥220mm For M: ≥230mm For L: ≥230mm For XL: ≥230mm | For L: 101-105mm For XL: 110mm Length: For S: 233~237mm For M: 233~237mm For L: 240~244mm For XL: 240~244mm Lot Batch of 20210719A: Width: For S: 79~83mm For M: 94~97mm For L: 101-104mm For XL: 110mm Length: For S: 234~236mm For M: 234~237mm For L: 240~244mm For XL: 240~245mm Lot Batch of 20210721C: Width: For S: 80~85mm For M: 94~98mm For L: 105-109mm For XL: 110mm Length: For S: 230~235mm For M: 235~238mm For L: 239~243mm For XL: 240~243mm Lot Batch of 20210716A: For S/M/L/XL: Thickness: Finger: ≥0.05mm Palm: ≥0.05mm | |----------------------------------------------|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |----------------------------------------------|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {8}------------------------------------------------ | | | | Finger min: 0.12mm Palm min: 0.08mm | | |---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | | | | Lot Batch of 20210719A: For S/M/L/XL: Finger min: 0.13mm Palm min: 0.08mm | | | | | | Lot Batch of 20210721C: For S/M/L/XL: Finger min: 0.13mm Palm min: 0.08mm | | | ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test | To determine the tensile strength and ultimate elongation before and after acceleration aging | Before Aging: Tensile Strength: ≥14Mpa Ultimate Elongation: ≥500% After Aging: Tensile Strength: ≥14Mpa Ultimate Elongation: ≥400% | For all three lots: Before Aging: Tensile Strength: ≥14Mpa Ultimate Elongation: ≥500% After Aging: Tensile Strength: ≥14Mpa Ultimate Elongation: ≥400% | Passed | | ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | AQL 2.5 | For all three lots: Pass at AQL 2.5 | Passed | | ASMT D6319-19 (ASTM D6124-11) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | < 2.0 mg/glove | Lot Batch of 20210716A: For S/M/L/XL: Pass at 0.12 mg/glove Lot Batch of | Passed | {9}------------------------------------------------ | | | 20210719A: For S/M/L/XL: Pass at 0.15 mg/glove Lot Batch of 20210721C: For S/M/L/XL: Pass at 0.21 mg/glove | |--|--|----------------------------------------------------------------------------------------------------------------------------------| |--|--|----------------------------------------------------------------------------------------------------------------------------------| #### 2) Biocompatibility Testing Summary: | Test Method | Test Purpose | Acceptance Criteria | Test Results | Conclusion | |----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------| | ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization | To evaluate the potential intracutaneous reactivity caused by intracutaneously inject the extract to rabbits | Under the conditions of study not an irritation | Under the conditions of study not an irritation | Passed | | ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization | To determine the skin sensitization potential in guinea pigs. | Under the conditions of the study not a sensitization | Under the conditions of the study not a sensitization | Passed | | ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for acute systemic toxicity | The test item was evaluated for acute systemic toxicity in ICR mouse | Under the conditions of the study no systemic toxicity | Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo. | Passed | # 8.2 Summary of Clinical Performance Test No clinical study is included in this submission. {10}------------------------------------------------ # 9. Final Conclusion: The subject device is a safe, as effective, and perform as well as or better than the legally marketed predicated K203593.

Medical nitrile examination gloves (Model: JL001)

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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Medical nitrile examination gloves (Model: JL001)

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

Section Matches

Product Code Matches

Special Control Matches

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