(66 days)
Not Found
No
The device description and performance studies focus on the physical and material properties of examination gloves, with no mention of AI or ML.
No
The device, disposable nitrile examination gloves, is intended to prevent contamination and is not described as treating or alleviating a medical condition or disease.
No
Explanation: The device is described as "Disposable Nitrile Examination Gloves" intended for "prevent[ing] contamination between patient and examiner." Its function is protective, not diagnostic. Diagnostic devices are used to identify or analyze diseases or conditions.
No
The device is a physical product (gloves) and the summary describes physical and biological testing, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description details physical characteristics of the gloves (material, color, size, sterility). It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Image processing, AI, DNN, or ML, which are sometimes associated with advanced IVD technologies.
The device is a medical device, specifically a Class I medical device (examination glove), but it falls under the category of a barrier device for infection control, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The subject device is powder free nitrile examination gloves. The subject device is in blue color. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's hands, medical purposes
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 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 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
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.
Summary of non-clinical performance testing:
- ASTM D6319 Physical Dimensions Test: Length(mm): S:≥220; M/L/XL:≥230; Width(mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10; Thickness (mm): Finger: ≥0.05, Palm: ≥0.05. Results: Length: S: > 220/Pass; M/L/XL: > 230/Pass; Width: S: 82-88 /Pass, M: 95-98/ Pass, L: 106-111/ Pass, XL:111-115/ Pass; Finger: 0.13-0.15/Pass, Palm: 0.09-0.12/Pass.
- ASTM D5151 Watertightness Test for Detection of Holes: Acceptance Criteria: Meet the requirements of ASTM D5151 AQL 2.5. Results: 0/125/Pass.
- ASTM D6124 Powder Content: Acceptance Criteria: Meet the requirements of ASTM D6124
§ 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 contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
December 4, 2022
Jiangxi Handspro Products Solutions CO., LTD. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161, East Lujiazui Rd.,Pudong Shanghai. 200120 China
Re: K223004
Trade/Device Name: Disposable Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 29, 2022 Received: September 29, 2022
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); medical device reporting (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/combinationproducts/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 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,
Bifeng Qian -S
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) K223004
Device Name Disposable Nitrile Examination Gloves
Indications for Use (Describe)
The Disposable Nitrile Examination Gloves are disposable devices intended for medical purposes that are 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)
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3
510(k) Summary K223004
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
| Name: | JIANGXI HANDSPRO PRODUCTS SOLUTIONS CO., LTD |
|---|---|
| Address: | Chuangye Avenue, Fenglin Industrial Zone of Dean County |
| Jiujiang City, Jiangxi, China. | |
| Tel: | +86-18616636918 |
| Contact: | Jun Yin |
Designated Submission Correspondent
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
|---|---|
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong, Shanghai |
| 200120 ,China | |
| Tel: | +86-21-50313932 |
| Contact: | Mr. Boyle Wang |
| Email: | Info@truthful.com.cn |
Date of Preparation: Sep.29th,2022
2.0 Device Information
| Trade name: | Disposable Nitrile Examination Gloves |
|---|---|
| Common name: | Patient Examination Gloves |
| Classification name: | Non-powdered patient examination glove |
| Model(s): | S, M, L, XL |
| Production code: | LZA |
| Regulation number: | 21CFR880.6250 |
| Classification: | Class I |
| Panel: | General Hospital |
3.0 Predicate Device Information
| Manufacturer: | GUANG DONG KINGFA SCI. & TECH.CO., LTD. |
|---|---|
| Device: | Nitrile examination gloves |
| 510(k) number: | K203593 |
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4.0 Indication for Use
The Disposable Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
5.0 Device Description
The subject device is powder free nitrile examination gloves. The subject device is in blue color. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
6.0 Technological Characteristic Comparison Table
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Subject Device | ||
| (K223004) | Predicate | ||
| Device | |||
| (K203593) | comparison | ||
| Product Code | LZA | LZA | same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable Nitrile | ||
| Examination Gloves are | |||
| disposable devices intended | |||
| for medical purposes that are | |||
| worn on the examiner's | |||
| hands to prevent | |||
| contamination between | |||
| patient and examiner. | 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-use, | |||
| powder-free, non-sterile | |||
| device. | Same | ||
| Material | Nitrile | Nitrile | Same |
| Powdered or | |||
| Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Colorant | Blue | Blue | 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
5
| Dimensions(mm) | Length: | Length: | same |
|---|---|---|---|
| S:≥220 | S:≥220 | ||
| M/L/XL:≥230 | M/L/XL:≥230 | ||
| Width: | Width: | ||
| S: 80±10 | S: 80±10 | ||
| M: 95±10 | M: 95±10 | ||
| L: 110±10 | L: 110±10 | ||
| XL: 120±10 | XL: 120±10 | ||
| Thickness(mm) | Finger:≥0.05 | Finger:≥0.05 |
| Palm: ≥0.05 | Palm: ≥0.05 | |||||
|---|---|---|---|---|---|---|
| Physical | ||||||
| Properties | Before | |||||
| Aging | Tensile | |||||
| Strength | 14MPa, min | Tensile | ||||
| Strength | 14MPa, min | Same | ||||
| Ultimate | ||||||
| Elongation | 500% min | Ultimate | ||||
| Elongation | 500% min | Same | ||||
| After | ||||||
| Aging | Tensile | |||||
| Strength | 14MPa, min | Tensile | ||||
| Strength | 14MPa, min | Same | ||||
| Ultimate | ||||||
| Elongation | 400%min | Ultimate | ||||
| Elongation | 400%min | Same | ||||
| Freedom from | ||||||
| Holes | Be free from holes when | |||||
| tested in accordance with | ||||||
| ASTMD5151 AQL=2.5 | Be free from holes when | |||||
| tested inaccordance | ||||||
| with | ||||||
| ASTMD5151 AQL=2.5 | same | |||||
| Powder Content | Meet the requirements of | |||||
| ASTM D6124 | Meet the | |||||
| requirements of | ||||||
| ASTM D6124 | Same | |||||
| Biocompatibility | ISO 10993-10. | |||||
| Under the conditions of the | ||||||
| study, not an irritant or a | ||||||
| sensitizer | ISO 10993-10. | |||||
| Under the conditions of | ||||||
| the study, not an irritant | ||||||
| or a sensitizer | Same | |||||
| ISO 10993-11. | ||||||
| Under the condition of | ||||||
| acute systemic toxicity test, | ||||||
| the test article did not show | ||||||
| acute systemic | ||||||
| toxicity in vivo. | ISO 10993-11. | |||||
| Under the condition | ||||||
| of acute systemic | ||||||
| toxicity test, the test | ||||||
| article did not show | ||||||
| acute systemic | ||||||
| toxicity in vivo. | same | |||||
| ISO 10993-5 | ||||||
| Under conditions of the | ||||||
| study, device extract is | ||||||
| cytotoxic | ISO 10993-5 | |||||
| Under conditions of the | ||||||
| study, device extract is | ||||||
| cytotoxic | same |
6
7.0 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 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests
for systemic toxicity.
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): | ||
| S:≥220; | |||
| M/L/XL:≥230; | |||
| Width(mm): | |||
| S: 80±10; | |||
| M: 95±10; | |||
| L: 110±10; | |||
| XL: 120±10 | |||
| Thickness (mm): | |||
| Finger: ≥0.05 | |||
| Palm: ≥0.05 | Length: S: > | ||
| 220/Pass; | |||
| M/L/XL: > 230/Pass | |||
| Width: | |||
| S: 82-88 /Pass | |||
| M: 95-98/ Pass | |||
| L: 106-111/ Pass | |||
| XL:111-115/ Pass | |||
| Finger: 0.13-0.15/Pass | |||
| Palm: 0.09-0.12/Pass | |||
| ASTM | |||
| D5151 | Watertightness | ||
| Test | |||
| for | |||
| Detection of | |||
| Holes | Meet the requirements of ASTM D5151 | ||
| AQL 2.5 | 0/125/Pass | ||
| ASTM | |||
| D6124 | Powder | ||
| Content | Meet the requirements of ASTM D6124 |