(196 days)
Not Found
No
The device description and performance studies focus on the physical properties and standards compliance of disposable nitrile gloves, with no mention of AI or ML.
No
The device, disposable nitrile gloves, is intended to prevent contamination and is not described as treating or alleviating a disease, injury, or disability.
No
The device is a disposable nitrile glove intended for contamination prevention, not for diagnosis of a condition.
No
The device is described as "Disposable nitrile gloves," which are physical objects worn on the hands. The description focuses on material, size, and physical properties, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be worn on the hands of examiners to prevent contamination between patient and examiner." This describes a barrier device for infection control, 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 confirms it's a "powder free nitrile examination glove." This aligns with a barrier device, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical 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 clearly described as a medical glove intended for personal protection and preventing cross-contamination. This falls under the category of general medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Disposable nitrile gloves are 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.
Product codes
LZA
Device Description
The Disposable nitrile gloves are powder free nitrile examination gloves. The Disposable nitrile gloves will be provided in blue. It can be available in four specifications: S,M,L and XL. And it 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
examiners
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 proposed device complies with the following standards:
- · ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitization. ●
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity. ●
- 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. .
- ASTM D6124-06, Standard Test Method for Residual Powder on Medical Gloves. .
Key results from the tests include:
- ASTM D6319 Physical Dimensions Test: Length(mm): >230/Pass; Width(mm): S: 85mm/Pass, M: 95mm/Pass, L: 105mm/Pass, XL: 115mm/Pass; Thickness (mm): Finger: 0.09-0.15/Pass, Palm: 0.06-0.07/Pass
- ASTM D5151 Watertightness Test for Detection of Holes: Pass
- ASTM D6124 Powder Content:
§ 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.
May 8, 2023
Holik Asia Group Co., Ltd % Libray Chang Official Correspondent Shanghai Spica Management Consulting Co., Ltd. 609 Room, No.133 Shengang Avenue, Pudong New District Shanghai, 201306 China
Re: K223280
Trade/Device Name: Disposable nitrile gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 12, 2023 Received: April 12, 2023
Dear Libray Chang:
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 -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
2
Indications for Use
510(k) Number (if known) K223280
Device Name Disposable nitrile gloves
Indications for Use (Describe)
The Disposable nitrile gloves are 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)
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3
510(K) Summary
K223280
| Type of submission | Traditional |
|---|---|
| Date prepared | April 12, 2023 |
| Submission sponsor | |
| Manufacturer Name | HOLIK ASIA GROUP CO.,LTD |
| Address | NO.18 Nanyi Road, Xuanzhou Economic Development |
| Zone, Liqiao Town, Xuanzhou District, Xuancheng City | |
| Anhui Province, China | |
| Tel | 86-13585161180 |
| monica@holikasia.com | |
| Contact Person | Monica Zhou |
| Device identification | |
| Trade Name | Disposable nitrile gloves |
| Regulation Number | 21 CFR 880.6250 |
| Regulation Name | Non-Powdered Patient Examination Glove |
| Device Classification | Class I |
| Product Code | LZA |
| Panel | General Hospital |
| Application correspondent | |
| Company Name | Shanghai Spica Management Consulting Co., Ltd. |
| Address | 609 Room, No.133 Shengang Avenue, Pudong New |
| District, Shanghai, China | |
| Tel | 86-13020102321 |
| Libray@spicagloble.com |
4
Contact Person
Libray Chang
Predicate device information
| Sponsor | Shanxi Nacosa Medical Technology Co.,Ltd |
|---|---|
| Trade/Device Name | Nitrile Examination Gloves |
| 510(K) number | K212924 |
| Regulation Number | 21 CFR 880.6250 |
Indications for use
The Disposable nitrile gloves are 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 description
The Disposable nitrile gloves are powder free nitrile examination gloves. The Disposable nitrile gloves will be provided in blue. It can be available in four specifications: S,M,L and XL. And it is non-sterile.
Performance Testing - Clinical
Not Applicable.
Performance Testing - Animal
Not Applicable.
5
Technological Characteristic Comparison
Provided below is a comparison of the subject device with the predicate device.
Table 6A: General Comparison
| Item | Subject Device K223280 | Predicate Device (K212194) | Comparison |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21 CFR 888.6250 | 21 CFR 888.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable nitrile gloves are 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. | 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 | Single-use indication, powder free, device color, | Single-use indication, powder free, device color, | Same |
6
| Information | device name,glove size and quantity, Non-Sterile | device name, glove size and quantity, Non-Sterile | ||||
|---|---|---|---|---|---|---|
| Dimensions(mm) | Length(mm): >230; | |||||
| Width(mm): | ||||||
| S: 85±5mm | ||||||
| M: 95±5mm | ||||||
| L: 105±5mm | ||||||
| XL: 115±5mm | ||||||
| Meet the requirements of ASTM D6319-19 | Length(mm): >230; | |||||
| Width(mm): | ||||||
| S: Average 84mm | ||||||
| M: Average 95mm | ||||||
| L: Average 111mm | ||||||
| XL: Average 115mm | ||||||
| Meet the requirements of ASTM D6319-19 | Similar | |||||
| Thickness(mm) | Finger: 0.09-0.15 | |||||
| Palm: 0.06-0.07 | Finger: 0.12-0.15 | |||||
| Palm: 0.08-0.10 | Similar | |||||
| Physical | ||||||
| Properties | Before Aging | Tensile Strength | ≥14MPa | Tensile Strength | 17-38 MPa | Similar |
| Ultimate Elongation | ≥500% | Ultimate Elongation | 501-565% | Similar | ||
| After Aging | Tensile Strength | ≥14MPa | Tensile Strength | 18-43MPa | Similar | |
| Ultimate Elongation | ≥400% | Ultimate Elongation | 500-564% | Similar | ||
| Freedom from Holes | Be free from holes when tested in accordance with | |||||
| ASTMD5151 | Be free from holes when tested in accordance with | |||||
| ASTMD5151 AQL=2.5 | Similar | |||||
| Powder Content | 230; | Length(mm): >230/Pass; | ||||
| Width(mm): | Width(mm): |
8
510(K) Summary
| S: 85±5mm | S: 85mm/Pass | ||||
|---|---|---|---|---|---|
| M: 95±5mm | M: 95mm/Pass | ||||
| L: 105±5mm | L: 105mm /Pass | ||||
| XL: 115±5mm | XL: 115mm/Pass | ||||
| Thickness (mm): | Thickness (mm): | ||||
| Finger: ≥0.05 | Finger: 0.09-0.15/Pass | ||||
| Palm: ≥0.05 | Palm: 0.06-0.07/Pass | ||||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | Pass | ||
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 |