(42 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device is described as a "patient examination glove" intended to "prevent contamination between patient and examiner," which is a protective barrier function, not a therapeutic treatment or diagnostic purpose.
No
The device is described as a glove worn on the examiner's hand to prevent contamination and is not used for diagnosing medical conditions.
No
The device is a physical glove, not software. The description clearly states it is a "powder free vinyl patient examination glove".
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 hand or finger. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on the physical properties and standards met by the glove (ASTM standards for examination gloves).
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
- No Mention of IVD-Specific Regulations or Standards: The standards mentioned (ASTM D 5250-06, D 6124-06, D 5151-06) are relevant to examination gloves, not IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This glove does not perform such a function.
N/A
Intended Use / Indications for Use
The powder free vinyl patient examination glove (non-sterile) 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. It is sold as non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
Powder Free Vinyl Patient Examination Gloves (Non-Sterile), that meets all of the requirement of ASTM standard D 5250-06, except for sterility requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Powder Free Vinyl Patient Examination Gloves (Non-Sterile) are summarized with the following technological characteristics compared to ASTM or equivalent standard.
Dimension: Meets ASTM D 5250-06
Physical Properties: Meets ASTM D 5250-06
Freedom from pinholes: Meets ASTM D5151-06
Powder Residual: Meets ASTM D5250-06 and D6124-06
Biocompatibility: Primary Dermal Irritation in Rabbits (ISO) Passes; Guinea Pig Closed Patch Sensitization Test (ISO) Passes
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.
0
Image /page/0/Picture/0 description: The image shows a company logo and contact information. The logo is for LPL (HUI ZHOU) GLOVE CO., LTD. The address is Daxiaotang village, Luoyang Town, Boluo County, Huizhou City, Guangdong Province, China, and the phone number is 0086-752-6863391. The fax number is 0086-752-6863392, the post code is 516120, and the email address is Info@lplglove.com. There is a date of JUL 20 2011 at the top right.
Section 5 510 (K) Summary (21 CFR 807.92) 510(K) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.
(applicant leave blank) The assigned 510(K) number is:
Premarket Notification [510(K)] Summary
[(a)(1)] The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared:
| Submitter's name:
Submitter's address: | LPL (Hui Zhou) Glove Co., Ltd.
Daxiaotang Village, Luoyang Town, Boluo County
Hui Zhou City, Guang Dong Province, 516120
China. |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Phone Number: | 0086-0752-6865040 |
| Fax Number: | 0086-0752-6863392 |
| Name of contact person: | Ms. Yew Sing Mei |
| Date the summary was prepared: | January 26, 2011 |
[(a)(2)| The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device/ Proprietary Name: | Powder Free Vinyl Patient Examination Gloves
(Non-Sterile) |
|---------------------------|---------------------------------------------------------------|
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | 1 |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product code: | LYZ |
[{a)(3)| An identification of the legally marketed device to which your firm is claiming substantial equivalence.
Predicate Device Information:
(1) K100978, "Powder-Free Non-Sterile Vinyl Examination Glove", manufactured by "Jiangsu Sunshine Plastic Products, Co., Ltd"
1
Image /page/1/Picture/0 description: The image shows the logo and contact information for LPL (HUI ZHOU) GLOVE CO., LTD. The logo features a stylized tree. The contact information includes the address, phone number (0086-752-6863391), fax number (0086-752-6863392), postal code (516120), and email address (Info@lplglove.com).
[(a)(4)] A description of the device
Device Description: Powder Free Vinyl Patient Examination Gloves (Non-Sterile), that meets all of the requirement of ASTM standard D 5250-06, except for sterility requirements.
The summary describes the intended use of the device ((a)(5)]
Device Intended Use: Powder Free Vinyl Patient Examination Gloves, (Non-Sterile) 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. It is sold as non sterile.
Comparison to Predicate Devices
The Powder free Vinyl patient examination gloves, non sterile are compared with the following Predicate Devices in terms of intended use, design, material, specification, and performance.
(1) K100978, "Powder-Free Non-Sterile Vinyl Examination Glove", manufactured by "Jiangsu Sunshine Plastic Products, Co., Ltd"
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
Table 5.1 Comparison of Intended Use, Design, and Material
| Description | Our Device | Predicate Device (K100978) |
|---|---|---|
| Indication for use | Disposable device intended for medical | |
| purposes that is worn on the | ||
| examiner's hand or finger to prevent | ||
| contamination between patient and examiner | Same | |
| Basic Design Material | Poly Vinyl Chloride | Same |
| Size | S, M, L, XL | Information unavailable |
| Single Use | Yes | Yes |
| Sterile | Non sterile | Non sterile |
2
Image /page/2/Picture/0 description: The image shows the logo and contact information for LPL (HUI ZHOU) GLOVE CO., LTD. The logo features a stylized tree graphic next to the letters "LPL". The contact information includes the company's address in Daxiaotang village, Luoyang Town, Boluo County, Huizhou City, Guangdong Province, China, as well as their telephone number (0086-752-6863391), fax number (0086-752-6863392), post code (516120), and email address (Info@lplglove.com).
[(a)(6)] A summary of the technological characteristics of new device compared to the predicate device
The Powder Free Vinyl Patient Examination Gloves (Non-Sterile) are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Our device | Predicate Device performance
(K100978) |
|-----------------------|------------------------------------------------------------------------------------------------|-------------------------------------------|
| Dimension | Meets ASTM D 5250-06 | Meets ASTM D 5250-06 |
| Physical Properties | Meets ASTM D 5250-06 | Meets ASTM D 5250-06 |
| Freedom from pinholes | Meets ASTM D5151-06 | Meets 21 CFR 800.20 |
| Powder Residual | Meets ASTM D5250-06 and D6124-06 | Meets ASTM D6124-06 |
| Biocompatibility | Primary Dermal Irritation in Rabbits (ISO)
Guinea Pig Closed Patch Sensitization Test (ISO) | Passes
Passes |
A brief discussion of the nonclinical submitted, reference, or relied on in the (b)(1)] premarket notification submission for a determination of substantial equivalence.
Powder Free Vinyl Patient Examination Gloves (Non-Sterile), meet the requirements per ASTM D5250-06, per ASTM D6124-06, and per ASTM 5151-06. It is safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended uses.
A brief discussion of the clinical submitted, reference, or replied on in the premarket ((b)(2)| notification submission for a determination of substantial equivalence,
Clinical data is not needed for gloves or for most devices cleared by the 510(K) process.
[(b)(3)] The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than legally marketed device identified in (a)(3).
Based on the comparison of intended use, design, materials, and performance, it can be concluded that our vinyl disposable examination gloves powder free non-sterile, meets the ASTM standard or equivalent standard and FDA requirements for water leak test on pinhole AQL., meet labeling Claims and are substantial equivalent to its predicate devices.
3
Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized symbol that resembles a human figure embracing or protecting something, with three curved lines above it.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
LPL (Hui Zhou) Glove Company, Limited C/O Ms. Camille D. Thornton Senior Regulatory Specialist Registrar Corporation Medical Device and Drug Divisions 144 Research Drive Hampton, Virginia 23666
JUL 20 2011
Re: K111598
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves (Non-Sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: July 8, 2011 Received: July 11, 2011
Dear Ms. Thornton:
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.
4
Page 2 - Ms. Thornton
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/ CDRH/CDRHOffices/ucm115 809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony O. nun
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form (Text Version)
Indications for Use Section 4:
Applicant: LPL (Hui Zhou) Glove Co., Ltd.
510(k) Number (if known):
Device Name: Powder Free Vinyl Patient Examination Gloves (Non-Sterile)
Indications for Use:
The powder free vinyl patient examination glove (non-sterile) 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. It is sold as non-sterile.
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rohit Ransulun
(Division Sign-Off) 7/18/2011
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number: K111598