(133 days)
No
The 510(k) summary describes a standard medical glove and makes no mention of AI, ML, image processing, or any related technologies. The performance studies focus on physical and biological properties of the glove.
No
This device is a patient examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.
No
Explanation: The device is described as a non-sterile disposable glove intended to prevent contamination between patient and examiner. There is no indication that it is used for diagnosing any condition or disease. Its performance studies focus on physical properties and biocompatibility, not diagnostic accuracy.
No
The device is a physical glove made of synthetic rubber, not software. The description focuses on material properties and physical standards.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens taken from the human body.
- Device Description: The description focuses on the material (synthetic rubber) and its function as a barrier, aligning with the intended use of a protective glove.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing. The performance studies focus on the physical properties and safety of the glove itself, not its ability to perform a diagnostic test.
Therefore, this device falls under the category of a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Powder Free Nitrile Patient Examination Gloves, White Color is a non-sterile 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
LZA
Device Description
Powder Free Nitrile Patient Examination Gloves, White Color are Device Description: Tree Tree Tritrile synthetic rubber , intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and 15 worn on the exammer 3 mand of the requirements of ASTM standard D 6319 00a (2005)el .
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
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
The device meets requirements per ASTM D6319 00a (2005)e1, per ASTM D6124-06, per 21 CFR 800.20 and ISO 10993-10: 2002/Amd. 1: 2006. Performance tests include dimension, physical properties, freedom from pinholes, powder residual, and biocompatibility (Primary Skin Irritation in rabbits and Dermal sensitization in the guinea pig).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Section C (rev.02)510(k) Summary (21 CFR 807.92)
510(K) Summary
JUN 1 0 2011
"This summary of 510(k) safety and effectiveness information is being submitted in This Sunmary - or -510(x) - Sales - SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: K110248
Premarket Notification {510(k)] Summary
| Submitter's name : | JiangSu DongLing Plastic & Rubber Co.,Ltd |
|---|---|
| Submitter's address : | DongWu Road, Economic Development Zone, |
| SuQian, JiangSu Province, 223800,China | |
| Phone number : | 0086-527-82860080 |
| Fax number : | 0086-527-82860080 |
| Name of contact person: | Mr.ZhiJun Xu |
| Date the summary was prepared: | Dec.24, 2010 |
| Device Name: | Powder Free Nitrile Patient Examination
Gloves, White Color |
|-------------------------|--------------------------------------------------------------------------------------------------|
| Proprietary/Trade name: | Powder Free Nitrile Patient Examination
Gloves, White Color
Other clients private labeling |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LZA |
Class I* Powder Free Nitrile Patient Examination Gloves,White Color that meets all of the requirements of ASTM D 6319 00a(2005)e1.
Predicate device: POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. K082598.
Device Description: Powder Free Nitrile Patient Examination Gloves,White Color are Device Description: Tree Tree Tritrile synthetic rubber , intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and 15 worn on the exammer 3 mand of the requirements of ASTM standard D 6319 00a (2005)el .
Section C
1
Device Intended Use (indication for use): Powder Free Nitrile Patient Examination Gloves. White Color 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 summary of the technological characteristics of new device compared to the predicate device.
The Powder Free Nitrile Patient Examination Gloves, White Color, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D 6319 00a (2005)e1. | Meets |
| Physical Properties | ASTM standard D 6319 00a (2005)e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 6319 00a (2005)e1. | |
| and D6124-06 | Trade/Device Name: Powder-Free Nitrile Patient Examination Glove, White Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examnation Glove Regulatory Class: I Product Code: LZA Dated: May 26, 2011 Received: May 26, 2011 |
Dear Mr. Xiaoan:
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.
3
Page 2- Mr. Xiaoan
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.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 vours,
Anthony D. asan
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
4
Section B Indications for Use
INDICATIONS FOR USE
JiangSu DongLing Plastic & Rubber Co.,Ltd -Applicant:
510(k) Number (if known):_* K 110248
Device Name: Powder Free Nitrile Patient Examination Gloves, White Color
Indications For Use:
Powder Free Nitrile Patient Examination Gloves, White Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F. (Lawrie-Williams
(Division Sign-Off) · Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KIIO248 510(k) Number: