(104 days)
Not Found
No
The device is a disposable medical examination glove, and the summary focuses on its physical properties and safety, with no mention of AI or ML.
No.
The device description clearly states it is a glove for preventing contamination, which is a barrier function, not a therapeutic one. It does not treat or alleviate a disease or condition.
No
The device is a disposable glove intended to prevent contamination, not to diagnose a medical condition.
No
The device is a physical product (gloves) and the summary describes physical and biological testing, not software characteristics or performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "worn on the examiner's hands to prevent contamination between patient and examiner." This describes a barrier device used for personal protection and infection control.
- Device Description: The description is of a physical barrier (a glove).
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens in this way.
- Performance Studies: The performance studies focus on the physical properties, safety, and barrier function of the glove, not on diagnostic accuracy or analysis of biological samples.
Therefore, the Disposable Nitrile Medical Examination Glove is a medical device, 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 Medical 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.
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 blue. 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, 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 10993-5:2009 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 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.
Key results:
- ASTM D6319 Physical Dimensions Test: Length: >230 mm; Width: XS: 77-79 mm, S: 82-86 mm, M: 95-97 mm, L: 104-106 mm, XL: 115-117 mm; Thickness: Finger: 0.08-0.13 mm, Palm: 0.06-0.10 mm. All Pass.
- ASTM D5151 Watertightness Test for Detection of Holes: XS: 0/125 leaks, S:1/125 leaks, M:0/125 leaks, L:0/125 leaks, XL:0/125 leaks. Pass.
- ASTM D6124 Powder Content: XS:0.01mg/glove; S:0.02mg/glove; M:0.03mg/glove; L:0.01mg/glove; XL:0.02mg/glove. Pass.
- ASTM D412 Physical properties - Before Aging: Tensile Strength: 15.3-19.2 MPa; Ultimate Elongation: 515-579%. Pass.
- ASTM D412 Physical properties - After Aging: Tensile Strength: 15.1-19.1 MPa; Ultimate Elongation: 405-468%. Pass.
- ISO 10993-5 Cytotoxicity: Under conditions of the study, did not show potential toxicity to L-929 cells. Pass.
- ISO 10993-10 Irritation: Under the conditions of the study, not an irritant. Pass.
- ISO 10993-10 Sensitization: Under conditions of the study, not a sensitizer. 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.
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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.
July 29, 2021
Siyang Threeguard Medical Supplies Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K211131
Trade/Device Name: Disposable Nitrile Medical 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 23, 2021 Received: June 28, 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 W. 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) K211131
Device Name Disposable Nitrile Medical Examination Glove
Indications for Use (Describe)
The Disposable Nitrile Medical 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)
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3
510(k) Summary (K211131)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Siyang Threeguard Medical Supplies Co.,Ltd. Address: East of Nanhai Road and South of Guilin Road,Economic Development Zone, Siyanq County,Sugian City,Jiangsu,223799 China. Phone Number: +86-13485097856 Contact: Guo Hua Date of Preparation: July.29,2021
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: Disposable Nitrile Medical Examination Glove Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS,S, M, L, XL
3.0 Classification
LZA Production code: Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
- Manufacturer: Ever Global (Vietnam) Enterprise Corp Disposable Powder Free Nitrile Examination Glove, White/ Device: Blue/ Black/ Pink Color
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510(k) number: K171422
5.0 Indication for Use
The Disposable Nitrile Medical 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
(K211131) | Predicate Device
(K171422) | Remark |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | Disposable Nitrile
Medical
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 Disposable
Powder Free Nitrile
Examination Glove,
White/ Blue/ Black/
Pink Color is a
disposable device
intended for
medical purposes
that is worn on the
examiner's hands
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 | Single-use
indication, powder
free, device color,
device name, glove
size and quantity,
Non-Sterile | Same |
Table1-General Comparison
5
| Non-Sterile | ||||
|---|---|---|---|---|
| -- | ------------- | -- | -- | -- |
| Predicate
| Device(K171422) | Designation | Size | Tolerance | |||||
|---|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | ||||
| Length, mm | 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 | ||||||||
| (K211131) | Designation | Size | Tolerance | |||||
| XS | S | M | L | XL | ||||
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | ||
| Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | ||
| Thickness, mm: | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| Remark | Same |
Table2 Device Dimensions Comparison
Table3 Performance Comparison
| Table3 Performance Comparison | |||||
|---|---|---|---|---|---|
| Item | Subject device | ||||
| (K211131) | Predicate 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 |
6
| Powder Content | Meet the requirements of ASTM D6124 230 |
| | | Width(mm):
XS: 75±5;
S: 85±5;
M: 95±5;
L: 105±5;
XL: 115±5 | Width:
XS: 77-79;
S: 82-86
M: 95-97
L: 104-106
XL: 115-117
Pass |
| | | Thickness (mm):
Finger: ≥0.05
Palm: ≥0.05 | XS:
Finger: 0.10-0.12
Palm: 0.06-0.10 |
| | | | S:
Finger: 0.09-0.12
Palm: 0.07-0.09 |
| | | | M:
Finger: 0.08-0.12
Palm: 0.06-0.09 |
| | | | L:
Finger: 0.09-0.13
Palm: 0.06-0.09 |
| | | | XL:
Finger: 0.11-0.12
Palm: 0.06-0.08
Pass |
| ASTM D5151 | Watertightness
Test for
Detection of
Holes | Meet the requirements of
ASTM D5151 AQL 2.5 | XS:
0/125 leaks
S:1/125 leaks
M:0/125 leaks |
8
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124