(113 days)
K#932550
Not Found
No
The device description and performance studies focus on the physical properties and testing of examination gloves, with no mention of AI or ML.
No.
The device description states it is a Class I device used to prevent contamination between patient and examiner/healthcare provider, not to provide therapy.
No
The device, a "Powder-Free Latex Examination Glove," is described as a disposable item worn to prevent contamination between a patient and an examiner. Its purpose is protective (preventing contamination), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly identifies the device as a physical glove made of latex, with specifications for length, thickness, width, and physical properties like tensile strength and elongation. It also describes physical testing methods like the water fill test for pinholes. This indicates a hardware device, not software.
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. This is a barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: It is described as a Class I device used for wearing on hands to prevent contamination. This aligns with a barrier device, not an IVD.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on physical properties and barrier integrity (water tightness, pinholes), which are relevant to a protective glove, not a diagnostic test.
- Standards: The standards mentioned (ASTM 3578-00 and FDA requirements for Patient Examination Gloves) are specific to examination gloves, not IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not perform any such function.
N/A
Intended Use / Indications for Use
A Powder-Free Latex Examination Glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
Patient Examination Gloves are a Class I device 21 CFR 880. They are used for wearing on hands of healthcare providers to prevent contamination from patient's or external environment.
The standards that are followed are as follows: ASTM 3578-00 and Food and Drug requirements for Patient Examination Gloves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care providers
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)
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
The physical specifications are as follows:
Length: 230 mm minimum
0.08 mm minimum Thickness:
Width: Small: 80 +/- 10 mm
Medium: 95 +/- 10 mm
Large: 110 +/- 10 mm
Physical Properties: (Minimum)
Before Aging
Tensile Strength: 21 Mpa
Ultimate Elongation: 700%
After Aging
Tensile Strength: 16 Mpa
Ultimate Elongation: 500%
Sampling and AQLs:
Water Tight Test: Sampling G-II, AQL 4.0
Dimensions: Sampling S-2, AQL 4.0
Pin hole testing is done in conformance with Food and Drug PIN HOLE TESTING: Administration's requirement of 1000 ml Water fill test method as described in Paragraph (b) Test method of the final rule entitled Patient Examination gloves and test Method for leakage defects: Adulteration, 55 CFR 51256 -51258, 21 CFR 800.20, The sampling plan is derived from MIL-STD-105E (MILITARY STANDARD FOR SAMPLING PROCEDURES AND TABLES FOR INSPECTION BY ATTRIBUTES) based on General Inspection Level G II, normal inspection and acceptable quality level of 4.0
Discussion of Clinical Tests Performed: Not Applicable
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.
K#932550
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
Attachment 11
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is:________________________________________________________________________________________________________________________________________________
Submitter's Identification: 1.
Safe Shield Co. Ltd. 43/2, K.M. 28, Surat-Takuapa Road Tambon: Bangduen, Amphur: Phun Phin Suratthani 84100, Thailand
Contact: Mr. Krishan Kumar Dwivedy, Managing Director of Safe Shield
Date Summary Prepared: December 28, 2001
2. Name of the Device:
Safe Shield Powder-Free Latex Examination Gloves
Predicate Device Information: 3.
K#932550, Powder-Free Patient Examination Gloves, Safe-Glove Ltd., Glendale, AZ
4. Device Description:
Patient Examination Gloves are a Class I device 21 CFR 880. They are used for wearing on hands of healthcare providers to prevent contamination from patient's or external environment.
The standards that are followed are as follows: ASTM 3578-00 and Food and Drug requirements for Patient Examination Gloves.
1
ട. Intended Use:
This powder-free latex examination glove is a disposable device intended for medical purposes in that it is worn on hands of health care providers or examiner's hand to prevent contamination between patient and examiner.
Comparison to Predicate Devices: 6.
The Safe Shield powder-free latex examination gloves are substantially equivalent in specifications, testing parameters, quality inspections and other physical attributes to Safe Gloves Co., Ltd. latex examination gloves and intended for same usages. There are no special labeling claims made for these gloves.
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
The physical specifications are as follows:
| Length: | 230 mm minimum |
|---|---|
| --------- | ---------------- |
- 0.08 mm minimum Thickness:
| Width: | Small: | $80 \pm 10$ mm |
|---|---|---|
| Medium: | $95 \pm 10$ mm | |
| Large: | $110 \pm 10$ mm |
Physical Properties: (Minimum)
| Before Aging | After Aging | |
|---|---|---|
| Tensile Strength | 21 Mpa | 16 Mpa |
| Ultimate Elongation | 700% | 500% |
| Sampling and AQLs: | ||
| Sampling | AQL |
| Water Tight Test | G-II | 4.0 |
|---|---|---|
| Dimensions | S-2 | 4.0 |
2
Pin hole testing is done in conformance with Food and Drug PIN HOLE TESTING: Administration's requirement of 1000 ml Water fill test method as described in Paragraph (b) Test method of the final rule entitled Patient Examination gloves and test Method for leakage defects: Adulteration, 55 CFR 51256 -51258, 21 CFR 800.20, The sampling plan is derived from MIL-STD-105E (MILITARY STANDARD FOR SAMPLING PROCEDURES AND TABLES FOR INSPECTION BY ATTRIBUTES) based on General Inspection Level G II, normal inspection and acceptable quality level of 4.0
Discussion of Clinical Tests Performed: 8.
Not Applicable
9. Conclusions:
The Safe Shield powder-free latex examination gloves are substantially equivalent in specifications, testing parameters, quality inspections and other equivalont in openifications, toosing partitle powder-free latex examination gloves pnysioal and for same usages. There are no special labeling claims made for these gloves.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by three intertwined lines, resembling a stylized human form, which symbolizes health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
MAY 6 - 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Safe Shield Company Limited C/O Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck. New York 11021
Re: K020053
Trade/Device Name: Safe Shield Powder-Free Latex Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 17, 2002 Received: April 19, 2002
Dear Ms. Falk:
This letter corrects our substantially equivalent letter of May 1, 2002 regarding the company name.
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). 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.
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 - Susan D. Goldstein-Falk
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of 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 yours,
Timothy A. Ulatowski Director Division of Dental. Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
Safe Shield Co. Ltd. Applicant:
510(k) Number (if known):* __ Ko 20053
Device Name: _Safe Shield Powder-Free Latex Examination Gloves
Indications For Use:
A Powder-Free Latex Examination Glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Chiu S. Lin
(Division Sign Org.
Prescription Use _ OR Per 21 CRF 801.109 (Optional Format 11-2-96) Over-The-Counter _
(Division Sign-Off) Division of Dental, Infection Control, and General Hospjtal Devices 510(k) Number
- For a new submission, do NOT fill in the 510(k) number.