(80 days)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
The provided text describes the acceptance criteria and performance of Powder Free Nitrile Examination Gloves, specifically focusing on their resistance to chemotherapy drugs and Fentanyl Citrate. It does not describe an AI/ML-based medical device. Therefore, many of the requested details about AI/ML specific studies (MRMC, standalone algorithm, training/test set ground truth establishment, expert qualifications, etc.) are not applicable to this document.
However, I can extract information related to the acceptance criteria and "studies" (non-clinical performance tests) conducted for this glove device.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Test Performed) | Reported Device Performance (Results) |
|---|---|
| Physical Dimensions (ASTM D6319-19) | |
| Length: Minimum 230mm for all sizes | Pass |
| Palm Width: XS: 70±10mm, S: 80±10mm, M: 95±10mm, L: 110±10mm, XL: 120±10mm, XXL: 130±10mm | Pass |
| Thickness: Finger: 0.05mm (min), Palm: 0.05mm (min) | Pass |
| Physical Properties (ASTM D6319-19, ASTM D412-16(2021)) | |
| Tensile Strength (Min 14 MPa) and Elongation (Before Aging 500% and After Aging 400%) Min | Pass |
| Water leak test (ASTM D6319-19, ASTM D5151-19) | AQL 2.5 (ISO 2859-1) - Pass |
| Powder Residue (ASTM D6319-19, ASTM D6124-06 (2017)) | Max 2mg/glove - Pass |
| Permeation by Chemotherapy Drugs (ASTM D6978-05 (2019)) | |
| Carmustine 3.3 mg/ml (3,300 ppm) | 11.3 minutes |
| Cisplatin 1mg/ml (1,000 ppm) | >240 minutes |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 minutes |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 minutes |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 minutes |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 minutes |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 minutes |
| Methotrexate, 25mg/ml (25,000ppm) | >240 minutes |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 minutes |
| Thiotepa, 10mg/ml (10,000ppm) | 24.7 minutes |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 minutes |
| Biocompatibility (ISO 10993-10 & 23:2021, ISO 10993-5:2009, ISO 10993-11:2017) | |
| Irritation and Skin Sensitization (Skin sensitization and Skin irritation) | Non-sensitization and Non-irritation |
| Cytotoxicity (Cytotoxicity reactivity) | Showed potential toxicity to L929 cells. (Note: Predicate device also showed cytotoxicity at higher concentrations but not at lower, suggesting this is an expected characteristic of the material at certain concentrations and likely within acceptable limits for a device of this type, given the "Similar" comparison to the predicate). |
| Acute systemic toxicity study (Subject showed no adverse biological reaction) | No evidence of systemic toxicity. |
2. Sample size used for the test set and the data provenance:
- The document refers to "Non-clinical tests" and lists various ASTM and ISO standards used. It does not specify the exact sample sizes used for each test beyond the requirements of these standards (e.g., AQL 2.5 for water leak test implies a specific sampling plan).
- Data Provenance: The document does not explicitly state the country of origin of the data for these non-clinical tests. It refers to Shanxi Hongjin Plastic Technology Co., Ltd. in China, which suggests the tests were likely performed in relation to their manufacturing and quality control processes. The tests are retrospective (i.e., performed on manufactured gloves to confirm compliance).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as this is a physical device (gloves) and the "ground truth" is established by adherence to physical and chemical testing standards (e.g., measuring dimensions, tensile strength, breakthrough detection time for chemicals per ASTM/ISO standards). These are objective measurements, not subjective expert interpretations of images or other data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for physical/chemical testing. The tests have defined methodologies and acceptance criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" for these tests is the objective measurement against established physical/chemical standards (e.g., actual dimensions, measured tensile strength, breakthrough time as defined by ASTM D6978-05). It's based on scientific and engineering measurements, not expert consensus, pathology, or outcomes data in a medical context.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device. There is no concept of a "training set" for physical product testing.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 9, 2023
Shanxi Hongjin Plastic Technology Co., Ltd. % Kathy Liu Project Manager Hongray(USA) Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K230779
Trade/Device Name: Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, ODO Dated: March 20, 2023 Received: March 21, 2023
Dear Kathy Liu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
{1}------------------------------------------------
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K230779
Device Name
Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentany) Citrate
Indications for Use (Describe)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | 11.3 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 24.7 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
510(K) SUMMARY
The assigned 510(K) numbers: K230779 Date Prepared: June 08, 2023
1. Owner's Identification:
Mr. Wu Zhigang Shanxi Hongjin Plastic Technology Co., Ltd. Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province Email: fdareg(@hongray.com.cn
Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Avenue, Chino, CA 91710, USA Tel: 909-590-1611 Email: kathyliu@hongrayusa.com
2. Name of the Device:
Trade / Product Name: Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Common Name: Exam Gloves Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, QDO, OPJ Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Comfort Rubber Gloves Industries Sdn. Bhd. Blue Colored, Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K192954)
4. Device Description:
Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
5. Indications for Use:
The Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019) The following chemicals have been tested with these gloves:
K230779 । । ર
{4}------------------------------------------------
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) inMinutes |
|---|---|
| Carmustine 3.3 mg/ml (3,300 ppm) | 11.3 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 24.7 |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
- Please note that the following drugs have extremely low permeation times: Carmustine: 11.3 minutes, Thiotepa: 24.7minutes, Or
*Warning: Do not use with Carmustine and Thiotepa.
6. Comparison of Subject Device and Predicate Device:
| Subject DeviceK230779 | Predicate DeviceK192954 | Comparison | |
|---|---|---|---|
| Trade Name | Powder Free NitrileExamination Gloves (Black),Tested for Use withChemotherapy Drugs andFentanyl Citrate | Blue Colored, Power Free NitrileExamination Gloves Tested forUse with Chemotherapy Drugs andFentanyl Citrate | Similar |
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | Powder Free Nitrile ExaminationGloves (Black), Tested for Usewith Chemotherapy Drugs andFentanyl Citrate is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand to preventcontamination between patientand examiner. Gloves have beentested for use with chemotherapydrugs and Fentanyl Citrate usingASTM D6978 | Blue Colored, Powder Free NitrileExamination Gloves, Non-sterile,and Tested for Use withChemotherapy Drugs and FentanylCitrate is a patient medical examglove which is a disposable deviceintended for medical purpose that isworn on the examiner's hand orfinger to prevent contaminationbetween examiner and patient.Glove was tested for use withChemotherapy Drugs and FentanylCitrate as per ASTM D6978 | Similar |
{5}------------------------------------------------
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County,
Linfen City, Linfen City, Shanxi Province
| Material | Nitrile | Nitrile | Same |
|---|---|---|---|
| Powder or Powder Free | Powder Free | Powder Free | Same |
| Color | Black | Blue | Different |
| Single use | Single use | Single use | Same |
| Chemotherapy Drugsand Fentanyl CitrateClaim | See below comparison table | See below comparison table | See belowcomparisontable |
Technological Characteristic Comparison Table:
| TechnologicalCharacteristics | Subject DeviceK230779 | Predicate DeviceK192954 | Comparison |
|---|---|---|---|
| Length | Minimum 230mm | Minimum 240mm | Similar |
| Palm Width (size) (mm) | |||
| XS | 70±10 | 70±10 | Same |
| S | 80±10 | 80±10 | Same |
| M | 95±10 | 95±10 | Same |
| L | 110±10 | 110±10 | Same |
| XL | 120±10 | 120±10 | Same |
| XXL | 130±10 | N/A | Different |
| Thickness(mm) | |||
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
| Tensile Strength, Before Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation,Before Aging | 500%, min | 500%, min | Same |
| Tensile Strength, AfterAccelerated Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, AfterAccelerated Aging | 400%, min | 400%, min | Same |
| Watertight (1000ml) | 21 CFR 800.20ASTM D5151AQL 2.5 | 21 CFR 800.20ASTM D5151AQL 2.5 | Same |
| Powder-Content | ≤2 mg per glove | ≤2 mg per glove | Same |
| 10993-23:2021 Skin IrritationStudy | Under the conditions ofthe study, not an irritant | Under the conditions of thestudy, the subject device isnon-irritating | Same |
| 10993-10:2021 MaximizationSensitization Study | Under the conditions of thestudy, not a sensitizer | Under the conditions of thestudy, the subject device isnon sensitization | Same |
{6}------------------------------------------------
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
| 10993-5:2009 CytotoxicityTest | Under the conditions of thisstudy, the test article extractshowed potential toxicity toL929 cells. | Exhibits severe cytotoxicityreactivity at 100%, and 66%extract concentrations and nocytotoxicity reactivity at 44%,30%, 20% and 15% extractconcentrations under thecondition of this test. | Similar |
|---|---|---|---|
| ISO 10993-11:2017 AcuteSystemic toxicity study | Under the conditions of thisstudy, there was no evidence ofsystemic toxicity. | Under the conditions of thestudy, the subject showed noadverse biological reaction. | Same |
Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:
| Tested Chemotherapy Drug andConcentration | Minimum BDT (Minutes) | Comparison | |
|---|---|---|---|
| Subject DeviceK230779 | Predicate DeviceK192954 | ||
| Carmustine 3.3 mg/ml (3,300 ppm) | 11.3 | 18.2 | Similar |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | Same |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | Same |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | Same |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | Same |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | Same |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | N/A | Different |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | Same |
| Thiotepa, 10mg/ml (10,000ppm) | 24.7 | 57.3 | Similar |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | Same |
7. Summary of Non-Clinical Performance Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| Methodology | Test Performed | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Physical DimensionsLength | Minimum 230mm for allsizes | Pass |
| ASTM D6319- 19 | Physical DimensionsPalm Width | XS: 70±10mmS: 80±10mmM: 95±10mmL:110±10mmXL: 120±10mm XXL:130±10mm | Pass |
| ASTM D6319- 19 | Physical DimensionsThickness | Finger: 0.05mm (min)Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19ASTM D412-16(2021) | Physical Properties | Tensile Strength (Min14MPa) and Elongation(Before Aging 500% andafter aging 400%) Min | Pass |
{7}------------------------------------------------
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province
| ASTM D6319-19ASTM D5151-19 | Water leak test | AQL 2.5 (ISO 2859-1) | Pass |
|---|---|---|---|
| ASTM D6319-19ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation byChemotherapy Drugs | Refer the above table | Pass |
| ISO 10993-10 &23:2021 | Irritation and SkinSensitization | Skin sensitization and Skinirritation | Is non-sensitizationand Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity | showed potentialtoxicity to L929 cells. |
| ISO 10993-11:2017 | Acute systemic toxicitystudy | Subject showed no adversebiological reaction | no evidence ofsystemic toxicity. |
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. ●
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves ●
- . ASTM D412-16 (2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- ASTM D6978-05 (Reapproved 2019), Assessment of Reissuance of Medical Gloves to Permeation by . Chemotherapy Drugs.
- ISO 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Tests For Skin Sensitization. .
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests For In Vitro Cytotoxicity ●
- ISO 10993-23:2021 Biological Evaluation of Medical Devices Part 10: Tests For Skin Irritation. ●
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity ●
8. Clinical Performance Data
N/A
9. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.
§ 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.