(19 days)
Not Found
No
The device is a patient examination glove, a simple barrier device. The description and testing focus on physical properties and biocompatibility, with no mention of AI/ML or related concepts.
No
A patient examination glove is intended to prevent contamination, not to treat or diagnose a disease or condition.
No
The device is a patient examination glove used to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device is a patient examination glove, which is a physical, disposable device made of rubber or similar material. The description clearly outlines physical testing and material standards, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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." This describes a barrier device used during physical examination, not a device used to examine specimens in vitro (outside the body).
- Device Description: The classification as a "Patient Examination Glove" under 21 CFR 880.6250 further confirms its purpose as a physical barrier.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The testing described (physical properties, water fill, skin irritation, residual powder) is relevant to the performance and safety of a glove as a barrier, not to its ability to perform an in vitro diagnostic test.
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
LZA
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00aE3.
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
The standards used for Shijiazhuang Tillotson Rubber Products Co., Ltd. glove production are based on ASTM-D-6319-00aE3. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level G-1, meeting these requirements. Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
A Residual Powder Test that based on ASTM D6124-01 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free' claims (contain no more than 2 mg powder per glove).
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
SEP 2 0 2004
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: _ k_042378
1. Submitter's Identification:
Mr. Yang Ying Shijiazhuang Tillotson Rubber Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei Province P.R. China
Date Summary Prepared: August 30, 2004
2. Name of the Device:
Shijiazhuang Tillotson Rubber Products Co., Ltd. Non-Sterile Powder-Free Blue Nitrile Patient Examination Glove
3. Predicate Device Information:
Tillotson Healthcare Corp.
True Advantage Non-Sterile Powder-Free Blue Nitrile Patient Examination Glove (K013016)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00aE3.
5. Intended 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.
1
6. Comparison to Predicate Devices:
Shijiazhuang Tillotson Rubber Products Co., Ltd. Non-Sterile Powder Free Blue Nitrile Patient Examination Glove is substantially equivalent in safety and effectiveness to the Tillotson Healthcare Corp. True Advantage Non-Sterile Powder Free Blue Nitrile Patient Examination Glove.
7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:
The standards used for Shijiazhuang Tillotson Rubber Products Co., Ltd. glove production are based on ASTM-D-6319-00aE3. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level G-1, meeting these requirements. Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
A Residual Powder Test that based on ASTM D6124-01 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free' claims (contain no more than 2 mg powder per glove).
8. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
9. Conclusions:
Shijiazhuang Tillotson Rubber Products Co., Ltd. Non-Sterile Powder Free Blue Nitrile Patient Examination Glove conform fully to ASTM-D-6319-00a€3 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract design featuring three stylized shapes that resemble birds in flight or flowing lines, stacked on top of each other.
SEP 2 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shijiazhuang Tillotson Rubber Products Compamy Limited Mr. James Chu Official Correspondent Gloveco, Incorporated 590 West Central Avenue, #D Brea, California 92821
Re: K042378
R042378
Trade/Device Name: Non-Sterile Powder Free Blue Nitrile Patient Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 1, 2004 Received: September 1, 2004
Dear Mr. Chu:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have rottewou your was 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 Interstate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to ac nove that metic Act (Act) that do not require approval of a premarket the rederal 1 004, Drag, and Sommay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providions of the sistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (500 as 1011). Existing major regulations affecting (1 Mr), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the becas nouncements concerning your device in the Federal Register.
3
Page 2 - Mr. Chu
Please be advised that FDA's issuance of a substantial equivalence determination does not Please oc auvisor that I DT 3 issuainse on that your device complies with other requirements Incall that I DX mas made a actes and regulations administered by other Federal agencies. of the Act of any I oderal blance tax sequirements, including, but not limited to: registration 1 ou must conting (21 CFR Part 801); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 et revers), systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in at a radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) Fins feter will and in Jose Finding of substantial equivalence of your device to a premitset notification. - The Pire results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desite specific at 12 mpliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Clus
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment A
INDICATIONS FOR USE
k 042378 510(k) NUMBER (IF KNOWN) : Shijiazhuang Tillotson Rubber Products Co., Ltd. APPLICANT: Non-Sterile Powder Free Blue Nitrile Patient Examination Glove DEVICE NAME:
INDICATIONS FOR USE:
A patient examination glove is 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 (Per 21 CFR 801.109) OR
Over-The-Counter-Use X (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE)
Kein Muly
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K042378