(402 days)
Not Found
No
The 510(k) summary describes a standard patient examination glove and contains no mention of AI or ML technology.
No.
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.
No.
The device is a patient examination glove, which is a barrier device for contamination prevention, not for diagnosis.
No
The device description clearly states it is a physical glove made from nitrile compound, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to prevent contamination between patient and examiner" by being worn on the hands or fingers. This is a barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description focuses on the physical characteristics of the glove (material, color, powder-free, size, etc.). There is no mention of any components or functions related to analyzing samples or providing diagnostic information.
- Lack of IVD-related information: The document does not mention any of the typical elements associated with IVDs, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic results or information about a patient's health status
- Reagents, calibrators, or controls
The device is clearly described as a patient examination glove, which is a medical device used for protection and hygiene, not for diagnosis.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The subject device in this 510(k) Notification is Nitrile Patient Examination Gloves, Powder Free, Pink Color. The subject device is a patient examination glove made from nitrile compound, pink color, powder free and non-sterile (Per 21 CFR 880.6250, class I).
These gloves are pink in color and are powder free. The gloves are ambidextrous single use disposable devices that come in six sizes (XS, S, M, L, XL and XXL).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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 Testing:
- Biocompatibility Testing:
- 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.
- Performance Testing:
- Physical performance testing conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves.
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves.
- 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.
Key Results:
- Dimensions (length, width, thickness) ASTM D6319-19: Pass. Length 240 mm min, Width for XS to XXL ranges from average 78.4mm to 123.5mm, Palm thickness 0.056mm min, Finger thickness 0.082mm min.
- Physical properties ASTM D6319-19: Pass. Before Aging: Tensile Strength 20.6MPa min, Elongation 531% min. After Aging: Tensile Strength 21.9MPa min, Elongation 416% min.
- Residual Powder ASTM D6124-06: Pass. Average 0.15 mg per glove (
§ 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
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August 24, 2023
Shandong YINGHONG Medical Products Co., Ltd. % Jason Ji Official Correspondent Intco Medical Industries, Inc 805 Barrington Ave. Ontario. California 91764
Re: K222103
Trade/Device Name: Nitrile Patient Examination Gloves, Powder Free, Pink Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 11, 2022 Received: July 21, 2023
Dear Jason Ji:
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 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,
Allan Guan -S
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222103
Device Name
Nitrile Patient Examination Gloves, Powder Free, Pink Color
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers 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
Shandong YINGHONG Medical Products Co., Ltd.
No.15 East Road, Hongrun Industry Park, Qingzhou, Shandong, China
510(K) SUMMARY K22103
1. Submitter's Identification:
Shandong YINGHONG Medical Products Co., Ltd No.15 East Road, Hongrun Industry Park, Qingzhou, Shandong, China
Contact Person :
Emily Dong Tel: +86-5366136888
Submission Correspondent
Company: Intco Medical Industries, Inc 805 Barrington Ave Ontario, CA 91764 Primary Contact Name: Jason Ji Tel: 1-909-980-1678 (Ext: 113) Email: jasonji@intcous.com Secondary Contact: John Zhao Tel: 1-909-980-1678 (Ext:112) Email: johnzhao@basicmedical.com
Date summary prepared:
August 10, 2023
Product Trade Name: Nitrile Patient Examination Gloves, Powder Free, Pink Color
3. Device Classification Name:
Non-Powdered Patient Examination Gloves
- Regulation Number: 4. 21 CFR 880.6250
- રે. Device Class: Class I.
- Product Code: 6. LZA.
-
- Predicate Devices: K190942 – Ever Growth (Vietnam) Co., Ltd.
4
8. Device Description:
The subject device in this 510(k) Notification is Nitrile Patient Examination Gloves, Powder Free, Pink Color. The subject device is a patient examination glove made from nitrile compound, pink color, powder free and non-sterile (Per 21 CFR 880.6250, class I).
These gloves are pink in color and are powder free. The gloves are ambidextrous single use disposable devices that come in six sizes (XS, S, M, L, XL and XXL).
Indications for Use: 9.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
| Characteristics
and Parameters | Shandong YINGHONG
Medical Products Co.,
Ltd.
Nitrile Patient
Examination Gloves,
Powder Free, Pink Color | Ever Growth (Vietnam) Co.,
Ltd.
Disposable Powder Free
Nitrile Examination Glove,
Pink Color | Comparison
Analysis |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| K-Number | K222103
(Subject Device) | K190942
(Predicate) | - |
| Product Code | LZA | LZA | Same |
| Regulation
Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Intended use | A patient examination
glove is a disposable
device intended for
medical purposes that is
worn upon the
examiner's hands or
finger to prevent
contamination between
patient and examiner. | The Nitrile Powder Free
patient examination glove is a
non- sterile disposable device
intended for medical purposes
that is worn on the examiner's
hands or finger to prevent
contamination between patient
and examiner. | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Pink | Pink | Same |
| Single Use | Yes | Yes | Same |
| Sterile vs
Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Powdered or
Powder Free | Powder Free | Powder Free | Same |
| | Complies with ASTM
D6319-19
Overall Length (mm)
For XS, S,
Min 220mm
For M, L, XL, XXL
Min 230mm | Complies with ASTM
D6319-10
Overall Length (mm)
For XS, S,
Min 220mm
For M, L, XL
Min 230mm | |
| | | | |
| Dimensions
ASTM
D6319-19 | Complies with
ASTM D6319-19
X-Small 70±10mm
Small 80±10mm
Medium 95±10mm
Large 110±10mm
X Large 120±10mm
XX Large 130 ±10mm | Complies with
ASTM D6319-10
X-Small 70±10mm
Small 80 ±10mm
Medium 95±10mm
Large 110±10mm
X Large 120 ±10mm
XX Large N/A | 1Different |
| | Thickness
Palm - 0.05mm min.
Finger - 0.05 mm min.
Meets ASTM D6319-19 | Thickness
Palm - 0.05mm min.
Finger - 0.05 mm min.
Meets ASTM D6319-10 | Same |
| Physical
properties
ASTM
D6319-19 | Tensile Strength:
Before Aging
14 MPa, min.
After Aging
14 MPa, min.
Elongation:
Before Aging 500% min.
After Aging 400% min. | Tensile Strength:
Before Aging
14 MPa, min.
After Aging
14 MPa, min.
Elongation:
Before Aging 500% min.
After Aging 400% min. | Similar |
| Freedom
from pinholes
ASTM
D6319-19
ASTM
D5151-19 | In accordance with
ASTM D6319-19 and
ASTM D5151- 19,
G-1, AQL 2.5 | In accordance with
ASTM D6319-10 and
ASTM D5151-06
G-1, AQL 2.5 | Similar |
| Residual
power test
ASTM
D6124-06 | Three Lot,
Average
power residue Performance Testing
Physical performance testing of the proposed device was conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves.
To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
· ASTM D6319-19 Standard Specification for Nitrile Examination Gloves.
- 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.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Dimensions | |||
| (length) (width) | |||
| (thickness) | |||
| ASTM | |||
| D6319-19 | The purpose of the test is | ||
| to evaluate the physical | |||
| dimension of the glove | Length | ||
| 220 mm min (XS, S) | |||
| 230 mm min (M, L, XL, XXL) | Pass | ||
| 240 mm min | |||
| Width (mm) | |||
| XS: 70±10 | |||
| S: 80±10 | |||
| M: 95±10 | |||
| L: 110±10 | |||
| XL: 120±10 | |||
| XXL: 130±10 | Pass | ||
| XS: average 78.4mm | |||
| S: average 86.2mm | |||
| M: average 97.4mm | |||
| L: average 108.7mm | |||
| XL: average 115.5mm | |||
| XXL: average 123.5mm | |||
| Thickness(mm): | |||
| Palm:Minimum 0.05 | |||
| Finger:Minimum 0.05 | Pass | ||
| Palm - 0.056mm min. | |||
| Finger - 0.082mm min | |||
| Physical | |||
| properties | |||
| ASTM | |||
| D6319-19 | The purpose of the test is | ||
| to evaluate the tensile | |||
| strength and ultimate | |||
| elongation before and | |||
| after aging | Before Aging: | ||
| Tensile Strength: 14 MPa, min. | |||
| Elongation: 500%, min. | |||
| After Aging: | |||
| Tensile Strength: 14 MPa, min. | |||
| Elongation: 400%, min. | Pass | ||
| Before Aging: | |||
| Tensile Strength: 20.6MPa, min. | |||
| Elongation: 531%, min. | |||
| After Aging: | |||
| Tensile Strength: 21.9MPa, min. | |||
| Elongation: 416%, min. | |||
| Freedom | |||
| from holes | |||
| ASTM | |||
| D5151-19 | The purpose of the | ||
| test is to detect holes in | |||
| the gloves | |||
| Residual | |||
| Powder | |||
| ASTM | |||
| D6124-06 | The purpose of the test is | ||
| to detect the powder | |||
| residue in the glove |