(87 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of examination gloves, with no mention of AI or ML.
No
The device, a disposable glove, is intended to prevent contamination between patient and examiner, fitting the definition of a general medical device rather than a therapeutic one which would involve treating or alleviating a disease or condition.
No
Explanation: The device description clearly states it is a "Powder-Free Latex Examination Glove" intended for preventing contamination. It does not perform any diagnostic functions like detecting, identifying, or monitoring a disease or condition.
No
The device is a physical product (gloves) made of natural rubber latex, 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 device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and standards met by the glove (latex, powder-free, ASTM standards). There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic tests.
- Lack of IVD Characteristics: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The device is a medical device, specifically a Class I medical device (examination glove), but it falls under the category of devices used for protection and barrier purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
The proposed device is Powder-Free Latex Examination Gloves. The gloves are single use and are provided non-sterile. The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The proposed device is provided with natural color. The device is available in two lengths, each with six sizes, extra-small (XS), small (S), medium (M), large (L) and extra-large (XL), and extra extra-large (XXL). The device is non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / 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)
Non clinical tests were conducted in accordance with following standards to verify that the subject device (short and long variants) met all design specifications.
Test: ASTM D3578-19 Tensile properties
Purpose: Demonstrate adequate tensile strength (unaged)
Criteria: Greater than 18 MPa
Result: Pass
Purpose: Demonstrate adequate elasticity at 500% elongation (unaged)
Criteria: Stress less than 5.5 MPa
Result: Pass
Purpose: Demonstrate adequate ultimate elongation (unaged)
Criteria: Greater than 650%
Result: Pass
Purpose: Demonstrate adequate tensile strength after aging
Criteria: Greater than 14 MPa
Result: Pass
Purpose: Demonstrate adequate ultimate elongation after aging
Criteria: Greater than 500%
Result: Pass
Test: ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
Purpose: Demonstrate glove integrity
Criteria: AQL 2.5
Result: Pass
Test: ASTM D6124-06(2017), Standard Test Method for Residual Powder on Medical Gloves
Purpose: Demonstrate low powder
Criteria: Less than 2.0 mg/glove
Result: Pass
Test: ASTM D5712-15, Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
Purpose: Demonstrate low level of extractable protein
Criteria: protein content not more than 200 µg/ dm²
Result: Pass
Test: ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Purpose: Demonstrate low potential for skin irritation
Criteria: Under the conditions of the testing, not an irritant
Result: Pass
Purpose: Demonstrate low potential for skin sensitizer
Criteria: Under the conditions of the testing, not a sensitizer
Result: Pass
Test: ISO 10993-11:2017, Biological evaluation of medical devices – Part 11:Tests for Systemic Toxicity
Purpose: Demonstrate low acute systemic toxicity
Criteria: Under the conditions of the testing, no acute systemic toxicity
Result: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
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.
Guangdong Kingfa Sci.&Tech. Co., Ltd. % Xiaoge Yu Manager Guangdong Kingfa Sci.& Tech.Co., Ltd. No.28, Delong Ave., Shijiao Town, Qingcheng District Qingyuan, Guangdong 511545 China
Re: K222612
Trade/Device Name: Powder-Free Latex Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: August 12, 2022 Received: August 30, 2022
Dear Xiaoge Yu:
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 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
1
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,
Digitally signed by Ramesh C. Ramesh C. Panquluri -S Panguluri -S Date: 2022.11.25 15:19:07 -05'00' For BiFeng Qian, M,D., 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) K222612
Device Name Powder-Free Latex Examination Gloves
Indications for Use (Describe)
The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner.
| 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) | X |
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3
510(k) Summary K222612
I. Submitter
GUANGDONG KINGFA SCI. & TECH.CO., LTD. No.28, Delong Ave., Shijiao Town, Qingcheng District, Qingyuan, Guangdong, China Contact person: Xiaoge Yu Position: Manager Tel.: +86-13570952157 E-mail: yuxiaoge@kingfa.com.cn Preparation date: November 21, 2022
II. Proposed Device
| Device Trade Name | Powder-Free Latex Examination Gloves |
|---|---|
| Common name: | Latex Patient Examination Gloves |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LYY |
| Review Panel | General Hospital |
III. Predicate Devices
| 510(k) Number: | K214017 |
|---|---|
| Trade name: | Examination gloves-Type A (Latex gloves) |
| Common name: | Latex Patient Examination Gloves |
| Classification: | Class I |
| Product Code: | LYY |
| Manufacturer: | Jiangxi Kemei Medical Apparatus & Instruments Group |
| Co., Ltd |
IV. Device description
The proposed device is Powder-Free Latex Examination Gloves. The gloves are single use and are provided non-sterile. The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The proposed device is provided with natural color. The device is available in two lengths, each with six sizes, extra-small (XS), small (S), medium (M), large (L) and extra-large (XL), and extra extra-large (XXL). The device is non-sterile.
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V. Indication for use
The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner.
VI. Comparison of technological characteristics with the predicate devices
| Item | Proposed device | Predicate device
(K214017) | Discussion |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Powder-Free Latex Examination Gloves | Examination gloves-
Type A
(Latex gloves) | - |
| Product Code | LYY | LYY | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Classification | Class I | Class I | Same |
| Powder free | Yes | Yes | Same |
| Indication for use | The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner. | The Examination gloves-Type A (Latex gloves) 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. | Similar |
| Main Material | Natural rubber latex | Natural rubber latex | Same |
| Color | Natural color | Natural White color | Similar |
| Size | X-Small, Small, Medium, Large, X-large, XX-large, | Small, Medium, Large | Similar |
| Palm width | X- Small(70±10mm)
Small (80±10mm)
Medium (95±10mm)
Large (110±10mm)
X-large (120±10mm) | Small (84-86mm)
Medium (96-98mm)
Large (105-108mm) | Similar |
| | XX-large (130±10mm) | | |
| Length | Short style
XS(220mm min)
S (220mm min)
M (230mm min)
L (230mm min)
XL (230mm min)
XXL (230mm min)
Long style
XS~XXL(280mm min) | ≥230mm | Similar |
| Thickness | Palm: 0.05mm min
Finger: 0.08mm min | Palm: 0.11-0.13mm
Finger:0.13-0.14mm | Similar |
| Freedom from
holes | Meets requirements
of ASTM D3578-19 | Meets requirements
of the ASTM D3578-19 | Same |
| Physical
Properties
(before aging) | Meets requirements
of ASTM D3578-19 | Meets requirements
of ASTM D3578-19 | Same |
| Physical
Properties
(after aging) | Meets requirements
of ASTM D3578-19 | Meets requirements
of ASTM D3578-19 | Same |
| Powder
residue | Meets requirements
of ASTM D3578-19 | Meets requirements
of ASTM D3578-19 | Same |
| Protein Content | Meets requirements
of ASTM D3578-19 | Meets requirements
of ASTM D3578-19 | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Shelf Life | - | 5 Years | Different |
| For single use | Yes | Yes | Same |
| Type of use | Over the counter use | Over the counter use | Same |
| Biocompatibility | Confirm to the
requirements of ISO
10993 series
standards | Confirm to the
requirements of ISO
10993 series
standards | Same |
Table 1 Comparison of Latex examination gloves
5
As above comparison, the differences in the dimensions of the subject and predicate device do not affect the safety and effectiveness of the device for its intended use. The biocompatibility test and performance test of the subject devices have been performed on the final finished device.
6
VII. Non-Clinical Testing
Non clinical tests were conducted in accordance with following standards to verify that the subject device (short and long variants) met all design specifications.
| Test | Purpose | Criteria | Result | |
|---|---|---|---|---|
| ASTM D3578-19 | ||||
| Tensile properties | Demonstrate | |||
| adequate tensile | ||||
| strength (unaged) | Greater than 18 MPa | Pass | ||
| Demonstrate | ||||
| adequate elasticity | ||||
| at 500% elongation | ||||
| (unaged) | Stress less than 5.5 MPa | Pass | ||
| Demonstrate | ||||
| adequate ultimate | ||||
| elongation | ||||
| (unaged) | Greater than 650% | Pass | ||
| Demonstrate | ||||
| adequate tensile | ||||
| strength after aging | Greater than 14 MPa | Pass | ||
| Demonstrate | ||||
| adequate ultimate | ||||
| elongation after | ||||
| aging | Greater than 500% | Pass | ||
| ASTM D5151-19 | ||||
| Standard Test | ||||
| Method for | ||||
| Detection of Holes | ||||
| in Medical Gloves | Demonstrate glove | |||
| integrity | AQL 2.5 | Pass | ||
| ASTM D6124- | ||||
| 06(2017), Standard | ||||
| Test Method for | ||||
| Residual Powder on | ||||
| Medical Gloves | Demonstrate low | |||
| powder | Less than 2.0 mg/glove | Pass | ||
| ASTM D5712-15, | ||||
| Standard Test | ||||
| Method for Analysis | ||||
| of Aqueous | ||||
| Extractable Protein | ||||
| in Natural Rubber | Demonstrate low | |||
| level of extractable | ||||
| protein | protein content not more | |||
| than 200 µg/ dm² | Pass | |||
| in Latex, Natural | ||||
| Rubber, and | ||||
| Elastomeric | ||||
| Products Using the | ||||
| Modified Lowry | ||||
| Method | ||||
| ISO 10993-10: | ||||
| 2010 Biological | ||||
| Evaluation Of | ||||
| Medical Devices - | ||||
| Part 10: Tests For | ||||
| Irritation And Skin | ||||
| Sensitization. | Demonstrate low | |||
| potential for skin | ||||
| irritation | Under the conditions of the | |||
| testing, not an irritant | Pass | |||
| Demonstrate low | ||||
| potential for skin | ||||
| sensitizer | Under the conditions of the | |||
| testing, not a sensitizer | Pass | |||
| ISO 10993- | ||||
| 11:2017, Biological | ||||
| evaluation of | ||||
| medical devices – | ||||
| Part 11:Tests for | ||||
| Systemic Toxicity | Demonstrate low | |||
| acute systemic | ||||
| toxicity | Under the conditions of the testing, no | |||
| acute systemic toxicity | Pass |
7
VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The conclusions drawn from the non-clinical testing demonstrate that the Powder-Free Latex Examination Gloves are as safe, as effective, and perform as well as or better than the predicate Examination gloves-Type A (Latex gloves) (K214017).