(259 days)
No
The device description and performance studies focus solely on the physical properties and biocompatibility of a standard examination glove, with no mention of AI/ML or related technologies.
No
A patient examination glove is intended to prevent contamination, not to treat a medical condition or disease.
No
The device is a patient examination glove, which is used to prevent contamination between patient and examiner. It does not analyze or interpret data to diagnose a condition.
No
The device description clearly states it is a "Powder Free Vinyl Patient Examination Glove," which is a physical, hardware device. The summary focuses on physical properties and performance standards for gloves, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove...worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a physical barrier device used during patient examination.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes. The device's function is purely a physical barrier.
The description and intended use align with a Class I or Class II medical device used for infection control during patient contact, not an IVD.
N/A
Intended Use / Indications for Use
A 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.
Product codes
LYZ
Device Description
Powder Free Vinyl Patient Examination Glove (Non-Sterile) is a patient examination glove available in S, M, L, XL. The glove is provided non-sterile and meets the entire requirement of ASTM standard D 5250-06.
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 / 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)
The subject device meets the requirements per ASTM D5250-06 and ASTMD6124-06 and ASTM 5151-06.
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity
- Irritation
- Skin sensitization
The device passed all biocompatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Dimension:
Length: >= 230mm
Width:
S size=85mm +/- 5mm
M size=95mm +/- 5mm
L size=105mm +/- 5mm
XL size=115mm +/- 5mm
Finger thickness >= 0.05mm
Palm thickness >= 0.08mm
Physical Properties:
Tensile strength >= 11MPa
Elongation >= 300%
Freedom from pinholes: No leaks; meets ASTM D5250-06 (AQL requirement: 2.5 with an accept/reject criteria of 2/3, sample size of 32)
Powder Residual: Powder residue
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, wave-like appearance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2015
LPL (Hui Zhou) Glove Co., Ltd. % Rhonda Alexander, M.S., M.P.A. Senior Regulatory Specialist Registrar Corp 144 Research Drive Hampton, Virginia 23666
Re: K150934
Trade/Device Name: Powder Free Vinyl Patient Examination Glove (Non-Sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 25, 2015 Received: November 27, 2015
Dear Rhonda Alexander:
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. 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150934
Device Name
Powder Free Vinyl Patient Examination Glove (Non-Sterile)
Indications for Use (Describe)
A 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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
UI ZHOU) GLOVE CO ..
地址: 中国广东省惠州市博罗县
罗阳镇大小塘村
电话: 0086-752-6863391
長真: 0086-752-6863392/3393
内页: www.lplglove.com
邮箱: Info@Iplglove.com
Daxiaotang village, Luoyang Town, Boluo County, Huizhou City, Guangdong Province, 516120 China. 0086-752-6863391 0086-752-6863392/3393 www.lplglove.com · Info@InIglove.com
510(k) Summary (21 CFR 807.92)
I. SUBMITTER
LPL (HUI ZHOU) GLOVE CO., LTD Daxiaotang Village, LuoYang Town, Boluo County Huizhou City, Guangdong Province 516120 China Tel: 00867526863391 Fax: 00867526863392 Email: info@lplglove.com Website: www.lplglove.com
Contact Person: Lee Hong Chong, Quality Assurance Date Prepared: December 8, 2015
II. DEVICE
| Name of Device: | Powder Free Vinyl Patient Examination Glove (Non-Sterile) |
|---|---|
| Classification Name: | Patient Examination Glove |
| Regulatory Class: | Class I |
| Product Code: | LYZ |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
III. PREDICATE DEVICE
| Name of Device: | Powder Free Non-Sterile Vinyl Examination Glove |
|---|---|
| Manufacturer: | Jiangsu Sunshine Plastic Products Co., Ltd. |
| K Number: | K100978 |
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission. There have been no previous submissions.
IV. DEVICE DESCRIPTION
4
Powder Free Vinyl Patient Examination Glove (Non-Sterile) is a patient examination glove available in S, M, L, XL. The glove is provided non-sterile and meets the entire requirement of ASTM standard D 5250-06.
V. INDICATIONS FOR USE
A 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.
VI. SUMMARY OF COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Powder Free Vinyl Patient Examination Glove (Non-Sterile) is compared with the following Predicate Devices in terms of intended use, design, material, specification, and performance.
- K100978: Powder –Free Non-Sterile Vinyl Examination Glove, manufactured by Jiangsu (1) Sunshine Plastic Products Co., Ltd
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| Description | Subject Device | Predicate Device K100978 |
|---|---|---|
| Indications for use | A 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. | The 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. | ||
| Vinyl Patient Examination Glove | ||
| (Non-Sterile) K150934 | Powder -Free Non-Sterile Vinyl | |
| Examination Glove | ||
| Material | Poly vinyl Chloride (PVC) | Poly vinyl Chloride (PVC) |
| Size | S, M, L, XL | S, M, L, XL |
| Single use | Yes | Yes |
| Sterile | Non-sterile | Non-sterile |
| Color | Clear | Clear |
Table 5.1 Comparison of Intended Use, Design, and Material
The Powder Free Vinyl Patient Examination Glove (Non-Sterile) is summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Subject device | Predicate device | ||
|---|---|---|---|---|
| K150934 | K100978 | |||
| Dimension | Length: $\geq$ 230mm | Meets | ASTM | D |
| Meets ASTM D5250-06 | 5250-06 | |||
| Width: | ||||
| S size=85mm $\pm$ 5mm | ||||
| M size=95mm $\pm$ 5mm | ||||
| L size=105mm $\pm$ 5mm | ||||
| XL size=115mm $\pm$ 5mm |
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| Finger thickness≥0.05mm | ||||
|---|---|---|---|---|
| Palm thickness≥0.08mm | ||||
| Physical Properties | Tensile strength≥11MPa | |||
| Elongation≥300% | ||||
| Meets ASTM D 5250-06 | Meets | |||
| 5250-06 | ASTM | D | ||
| Freedom from pinholes | No leaks; meets ASTM D5250-06 | |||
| (AQL requirement: 2.5 with an accept/reject | ||||
| criteria of 2/3, sample size of 32) | Meets | |||
| 800.20 | 21 | CFR |
| Powder Residual | Powder residue ≤1.1
Meets ASTM D5250-06 and D6124-06 | Meets ASTM D 5250-06 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Cytotoxicity
(ISO 10993-5: 2009) | Under the conditions of the study, not cytotoxic | N/A |
| Biocompatibility
(ISO 10993-10: 2010) | Primary Dermal Irritation in rabbits-under the conditions of the study, not an irritant
Dermal Sensitization in the guinea pig-under conditions of the study, not a sensitizer | Passes
Passes |
Summary of Similarities and Differences
The device is similar in design and appearance, and has the same intended use and performance characteristics to the predicate device. The device has a different type of plasticizers from the predicate device and the plasticizer content is non phthalate. The differences between the subject devices and the predicate do not raise new questions of safety and effectiveness.
VII. PERFORMANCE DATA/TESTING
The subject device meets the requirements per ASTM D5250-06 and ASTMD6124-06 and ASTM 5151-06.
Biocompatibility Testing
The subject device is considered to be a surface device for intact skin, with limited duration (